BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATYPUS BOWEL GRASPER

    MDR report key: 3181436 · Received June 3, 2013

    Report

    Report Number
    3181436
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 15, 2013
    Report Date
    June 3, 2013
    Manufacturer
    KARL STORZ GMBH & CO. KG
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PART OF THE PLATYPUS GRASPER BROKE OFF DURING LAPAROSCOPIC SURGERY BUT WAS EASILY REMOVED USING ANOTHER INSTRUMENT. NO PATIENT HARM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC SURGERY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244277 PLATYPUS BOWEL GRASPER LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ KARL STORZ GMBH & CO. KG * *

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR