BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER

    MDR report key: 3958395 · Received June 12, 2014

    Report

    Report Number
    9610617-2014-00028
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    February 14, 2014
    Report Date
    May 13, 2014
    Manufacturer
    KARL STORZ GMBH & CO.
    Product Code
    GCJ
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INSTRUMENT WAS NOT RETURNED FOR EVALUATION. THE MOST LIKELY CAUSE OF BREAKAGE IS OVERSTRESS; INSTRUMENT NOT DESIGNED TO RETRACT OR MOVE HEAVY TISSUE.

    Description of Event or Problem · 1

    ALLEGEDLY, WHILE PERFORMING A CYSTOSCOPY, ONE JAW OF THE GRASPER BROKE OFF INTO PATIENT. THE DOCTOR IMMEDIATELY RETRIEVED PIECE AND WENT ON TO COMPLETE PROCEDURE. XRAY CONFIRMED THAT NOTHING REMAINED IN PATIENT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347125 BOWEL GRASPER BOWEL GRASPER GCJ KARL STORZ GMBH & CO. 33310C

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention