BEUDAMED
    FDA Adverse Event Other Summary report: N

    FENESTRATED GRASPER FORCEPS TIP

    MDR report key: 3004238 · Received March 12, 2013

    Report

    Report Number
    1223422-2013-00006
    Event Type
    Other
    Date Received
    March 12, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    PMA / PMN Number
    K981389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE REF 3222 TIP WAS RETURNED, DECONTAMINATED AND INVESTIGATED. THE RETURNED TIP WAS DISASSEMBLED AND ALL OF THE COMPONENTS, EXCEPT FOR THE JAW WITH THE BROKEN HINGE, WERE INSPECTED AND WERE FOUND TO BE WITHIN SPEC. IT WAS OBSERVED THAT THE TEETH OF THE JAW WERE BENT WIT ALIGNMENT TO THE CENTER OF THE HOLE, WHICH MAY RESULT IN RELIEVING STRESS AFTER THE HINGE WAS BROKEN. ALSO, TOOL MARKS WERE FOUND ON THE FRONT HUB UNDER >10X MAGNIFICATION. THE CAUSE FOR THE TOOL MARKS COULD NOT BE DETERMINED. THE COMPLAINT WAS REPLICATED BY HOLDING A RIGID ROD AT THE PROXIMAL END OF A TIP (REF 3222 WITH AN UNK LOT NUMBER) THAT WAS THREADED ONTO A TEST HANDPIECE AND FORCE APPLIED. NO ADD'L COMPLAINTS HAVE BEEN RECEIVED FOR THE LOT NUMBER LISTED. THERE IS NO REMAINING PRODUCT WITH THIS LOT NUMBER IN HOUSE TO EXAMINE.

    Description of Event or Problem · 1

    DURING SURGERY, THE TIP CAME APART AT THE HINGE. NO PT INJURY. NO ADD'L PT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104221 FENESTRATED GRASPER FORCEPS TIP FENESTRATED TIP GEI MICROLINE SURGICAL INC 3222 00109221

    Patients

    Seq Age Sex Outcome Treatment
    1