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DISSECTOR FORCEPS LINVATEC CORPORATION Reports 1998-2010
Medical Device Brand Name: ENDO CRILE DISSECTOR FORCEPS
Medical Device Generic Name: DISSECTOR FORCEPS
Medical Device Manufacturer Name:LINVATEC CORPORATION


DISSECTOR FORCEPS LINVATEC CORPORATION Report # 298762
DURING A SURGICAL PROCEDURE, A SCREW CAME OUT OF THE INSTRUMENT AND FELL INTO THE SURGICAL SITE. THE DR ELECTED NOT TO LOOK FOR THE SCREW. THE SCREW WAS VERIFIED TO BE IN THE PT DURING A POST-OPERATIVE X-RAY. THE PT WAS INFORMED. PER THE DR 'THERE DOES NOT APPEAR TO BE ANY ADVERSE EFFECTS'.

DISSECTOR FORCEPS LINVATEC CORPORATION Report # 298762
DATE OF THIS REPORT 09/29/2000. NO MEDWATCH REC'D FROM USER FACILITY. ALL SECTIONS OF THIS FORM COMPLETED BY MFR. INVESTIGATIVE SUMMARY: CUSTOMER COMPLAINT VERIFIED. THE ENDO CRILE DISSECTOR FORCEPS WERE REC'D INTO EVALUATION WITH THE HEAD OF THE JAW SCREW MISSING. THE DETACHED PORTION OF THE SCREW HEAD (APPROXIMATELY 0.10" X 0.045" DIAMETER) WAS NOT RETURNED WITH THE DEVICE. INSTRUMENT WAS DISASSEMBLED AND REASSEMBLED INCORRECTLY WITH A 0.031" GAP BETWEEN THE ROTATING FLUSH KNOB AND THE HANDLE FACE. THE JAW SCREW WAS SUBJECTED TO A HIGHER LOAD SINCE THE LINKAGE TRAVELED AN ADDITIONAL 0.010" IN ORDER FOR THE JAWS TO FULLY CLOSE. THE CAUSE OF THE SHEARING OF THE JAW SCREW WAS EXCESSIVE FORCE.

DISSECTOR FORCEPS LINVATEC CORPORATION Report # 366328
INVESTIGATED SUMMARY: THE COMPLAINT WAS VERIFIED. THE DEVICE WAS RETURNED WITH THE HEAD HALF OF THE JAW PIVOT SCREW DETACHED. THE DETACHED PORTION OF THE SCREW, APPROXIMATELY (.10"L X .045"D) WAS NOT RETURNED WITH THE DEVICE. THE SCREW WAS SHEARED FROM GRASPING A HARD MATERIAL AND APPLYING EXCESSIVE FORCE TO THE HANDLES. THE PORTION OF THE SCREW REMAINING WAS DEFORMED AND PEENED. IT WAS ALSO NOTED THAT THE DISTAL TEETH OF THE BOTTOM JAW WERE SEVERELY DEFORMED AND THE TEETH OF THE TOP JAW WERE GALLED/PEENED, WHICH CONFIRMS EXCESSIVE FORCE. THE UNIT HAS NOT BEEN RETURNED FOR SERVICE SINCE 2/2000.

DISSECTOR FORCEPS LINVATEC CORPORATION Report # 366328
DURING LAPAROSCOPIC GALL BLADDER PROCEDURE THE JAW SCREW SHEARED AND FELL INTO THE WOUND. THE DOCTOR WAS UNABLE TO LOCATE THE SCREW HEAD AND ELECTED TO LEAVE IT. THE PT WAS INFORMED AND AGREED WITH THE DOCTOR. NO ADVERSE EFFECTS REPORTED.

DISSECTOR FORCEPS LINVATEC CORPORATION Report # 449081
DURING AN ENDOSCOPIC APPENDECTOMY PROCEDURE THE DEVICE ARCED ELECTRICITY FROM CRACK/CHIPPED SIDE OF INSULATED SHAFT CAUSING SEVERAL BURNS AND A CUT IN THE WALL OF THE SIGMOID COLON. AREAS OF COLON WERE OVERSEWN WITH SUTURE.

DISSECTOR FORCEPS LINVATEC CORPORATION Report # 449081
INVESTIGATIVE FINDINGS: WHEN THE DISSECTOR WAS RECEIVED, THERE WAS A VISIBLE BURN MARK IN THE INSULTATION THAT EXPOSED THE INNER METAL TUBE. THIS BURN MARK AND/OR MISSING INSULATION WAS APPROXIMATELY THREE INCHES FROM THE DISTAL TIP. THE BURN MARK IN THE INSULATION MAY HAVE BEEN CAUSED BY ANOTHER HEAT GENERATING DEVICE THAT CAME INTO CONTACT WITH THE INSULATION. OR THE BURN MARK/MISSING INSULATION MAY HAVE BEEN CAUSED BY LAYING THE DISSECTOR ON THE EDGE OF THE STERILIZATION TRAY IN THE AUTOCLAVE, WHICH CAUSED THE INSULATION TO MELT AND EXPOSE THE INNER METAL TUBING. PRODUCT INSERT INSTRUCTS THE USER TO: 1. INSPECT THE INSTRUMENT FOR PROPER FUNCTION. 2. INSPECT FOR BROKEN, CRACKED OR WORN PARTS OR BREAKS IN THE INSULATION. 3. DISCONTINUE USE OF ANY ELECTROSURGICAL PRODUCT IF UNUSUAL OPERATING CHARACTERISTICS DEVELOP OR ARE OBSERVED DURING A PROCEDURE.


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Source: Manufacturer and User Facility Device Experience Database - (MAUDE). MAUDE data represents reports of adverse events involving medical devices. The data consists of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19. MAUDE is scheduled to be updated quarterly and the search page reflects the date of the most recent update. MAUDE data is not intended to be used either to evaluate rates of adverse events or to compare adverse event occurrence rates across devices. Please be aware that reports regarding device trade names may have been submitted under different manufacturer names. Searches only retrieve records that contain the search term(s) provided by the requester. The data is updated on a quarterly basis. DISCLAIMER: Section 21 CFR 803.16 states that "A report or other information submitted by a reporting entity under this part, and any release by FDA of that report or information, does not necessarily reflect a conclusion by the party submitting the report or by FDA that the report or information constitutes an admission that the device, or the reporting entity or its employees, caused or contributed to the reportable event. The reporting entity need not admit and may deny that the report or information submitted under this part constitutes an admission that the device, the party submitting the report, or employees thereof, caused or contributed to a reportable event." In addition, some firms have submitted their own additional disclaimer statements. A file of those disclaimers will be placed on the web shortly.
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