BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSERT, BOWEL GRASPER, FENESTRATED

    MDR report key: 10079606 · Received May 21, 2020

    Report

    Report Number
    9610617-2020-00066
    Event Type
    Malfunction
    Date Received
    May 21, 2020
    Date of Event
    March 4, 2020
    Report Date
    May 19, 2020
    Manufacturer
    KARL STORZ SE & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K935071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM HAS NOT BEEN RETURNED BY THE FACILITY, THEREFORE, NO EVALUATION CAN BE DONE.

    Description of Event or Problem · 1

    ALLEGEDLY, PER MEDWATCH REPORT 5093928, DURING A LAPAROSCOPIC PROCEDURE, ONE OF THE GRASPER TIP FELL INTO THE PATIENT, THE TIP WAS REMOVED, X-RAY WAS PERFORMED AND NOTHING REMAINED IN THE PATIENT, NO OTHER INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543898 INSERT, BOWEL GRASPER, FENESTRATED BOWEL GRASPER, FENESTRATED JAWS GCJ KARL STORZ SE & CO. KG 33410C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention