BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETACHATIP MULTI-USE GRASPERS, BLUNT NOSE DISSECTOR, 5MMX 33CM

    MDR report key: 3852179 · Received June 5, 2014

    Report

    Report Number
    1320894-2014-00063
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    CONMED CORPORATION
    Product Code
    GEI
    PMA / PMN Number
    K123260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETAINED BY THE END-USER FACILITY AND WILL NOT BE RETURNED TO CONMED CORPORATION FOR EVALUATION. ON COMPLETION OF THE QUALITY ENGINEERING EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED. THIS IS BEING REPORTED DUE TO A SENTINEL EVENT REPORTED ON MEDWATCH 1320894-2013-00015. DEVICE RETAINED BY HOSPITAL.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE DAMAGED DETACHATIP MULTI USE GRASPERS, BLUNT NOSE DISSECTOR WAS RETAINED BY THE USER FACILITY AND NOT RETURNED TO CONMED FOR EVALUATION. WITHOUT THE INVOLVED INSTRUMENT, AN EVALUATION AND PHYSICAL EXAMINATION OF THE INSTRUMENT COULD NOT BE PERFORMED AND THUS THE EXACT CAUSE OF THE BREAKAGE COULD NOT BE DETERMINED. HOWEVER, PHOTOS OF THE DAMAGED INSTRUMENT WERE PROVIDED, WHICH SHOWED ONE OF THE JAWS WAS COMPLETELY DETACHED AND THIS CONFIRMED THE REPORTED BREAKAGE. THE LOCATION OF THE BREAK WAS AT THE CAM SLOT IN THE JAW TAIL PIECE, WHERE CROSS SECTIONAL AREA (MATERIAL THICKNESS) IS THE SMALLEST. THIS INSTRUMENT WAS MANUFACTURED ON 29-JAN-2014. OF THE LOT CONTAINING (B)(4) UNITS, THERE WERE NO OTHER SIMILAR COMPLAINTS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT # FOUND NO NOTED OF DISCREPANCIES DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED BREAKAGE. HOWEVER, THE DHR CONFIRMED THAT THE GRASPER JAW COMPONENTS (13540 &13541 USED IN THIS LOT #1401291 HAVE THE VENDOR LOT (#740540 AND #702929), WHICH THE CERTIFICATES OF CONFORMANCE SHOWED AS MANUFACTURED ON 12-NOV-2013 AND 12-MAR-2013 THAT WERE PRIOR TO THE IMPLEMENTATION OF THE SCAR CORRECTIVE ACTION. A 2-YEAR REVIEW OF THE COMPLAINT HISTORY FOR THIS DEVICE FAMILY SHOWED SEVEN (7) SIMILAR REPORTS OF JAW BREAKAGE. DURING THIS SAME TIME FRAME, OVER (B)(4) UNITS WERE SOLD WORLDWIDE, MAKING THE RATE OF OCCURRENCE FOR THIS FAILURE MODE AT (B)(4). IT SHOULD BE NOTED, OF THE 7 REPORTS OF JAW DETACHMENTS, THERE HAS BEEN ONLY ONE (1) REPORT RESULTING IN A SERIOUS INJURY. TO DATE, THERE HAS BEEN NO PATIENT LONG TERM ADVERSE EFFECT REPORTED REGARDING THAT INCIDENT. THE DETACHATIP MULTI-USE GRASPERS, BLUNT NOSE DISSECTOR IS A MULTI-USE LAPAROSCOPIC DISSECTOR INTENDED TO DISSECT TISSUE IN A VARIETY OF ENDOSCOPIC PROCEDURES. THIS IS A REUSABLE DEVICE HAS BEEN IN USE FOR APPROXIMATELY OVER THREE MONTHS, AND THE NUMBER OF SURGICAL USES AND STERILIZATION CYCLES WAS NOT PROVIDED. THE IFU (INSTRUCTIONS FOR USE), STATES THAT "DETACHATIP LAPAROSCOPIC INSTRUMENTS HAVE BEEN VALIDATED FOR THIRTY (30) STEAM STERILIZATION CYCLES. THE USEFUL LIFESPAN OF A SURGICAL INSTRUMENT IS LARGELY DEPENDENT ON THE CARE AND HANDLING OF THE INSTRUMENT. FOR OPTIMAL LIFE, PROTECT THE DETACHATIP INSTRUMENTS FROM CONTACT WITH OTHER INSTRUMENTS DURING CLEANING AND RE-STERILIZATION". FINAL DETERMINATION OF THE DEVICE LIFETIME IS AT THE DISCRETION OF THE OPERATOR. THUS, DEVICE DAMAGE DURING CLEANING AND HANDLING COULD ALSO CONTRIBUTE TO ITS USEFUL LIFE SPAN. TO REDUCE THE RISK OF THE JAW BREAKAGE AND THE PATIENT INJURY, THE IFU PROVIDES THE FOLLOWING WARNINGS: - AVOID OVERSTRESSING MECHANISMS OF INSTRUMENTS BY PROPERLY GRIPPING AND MANEUVERING DURING SURGERY. - IF EXCESSIVE FORCE IS APPLIED, THE MECHANISM CAN BE EASILY OVERSTRESSED RESULTING IN DAMAGE OR BREAKAGE". THE DATE OF THIS REPORT WAS REPORTED IMPROPERLY ON THE INITIAL SUBMISSION OF THIS MEDWATCH AND THE CORRECTED DATE OF 05/09/2014. THE DEVICE MANUFACTURE DATE WAS REPORTED INCORRECTLY ON THE INITIAL SUBMISSION OF THIS MEDWATCH AND THE CORRECT DATE IS 01/29/2014. DEVICE RETAINED BY END-USER FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED, "DTIP BULLET NOSE GRASPER BROKE OFF INSIDE ANOTHER PATIENT." IT WAS ALSO REPORTED THAT THERE WAS NO PATIENT INJURY, AND, BROKEN PIECE WAS RETRIEVED AND REMOVED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329520 DETACHATIP MULTI-USE GRASPERS, BLUNT NOSE DISSECTOR, 5MMX 33CM D-TIP BLUNT NODE DISSECTOR GEI CONMED CORPORATION 1401291

    Patients

    Seq Age Sex Outcome Treatment
    1