BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER FORCEPS INSERT

    MDR report key: 6333970 · Received February 15, 2017

    Report

    Report Number
    9610617-2017-00007
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    December 1, 2016
    Report Date
    January 18, 2017
    Manufacturer
    KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY
    Product Code
    FCL
    PMA / PMN Number
    K935070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CONFIRMED THAT ONE JAW BROKE COMPLETELY OFF THE INSTRUMENT. THE INSTRUMENT HAS A DATE CODE OF GB ((B)(4)) AND IT HAS BEEN IN USE FOR APPROXIMATELY 8 1/2 YEARS. DAMAGE IS CONSISTENT WITH WEAR OF LONG USE/ STRESS OVERLOAD.

    Description of Event or Problem · 1

    ALLEGEDLY, DURING A LAPAROSCOPIC PROCEDURE THE DOCTOR NOTED THAT A JAW BROKE OFF THE INSTRUMENT AND FELL INTO THE PATIENT'S ABDOMEN. THE DOCTOR IMMEDIATELY REMOVED THE BROKEN JAW AND REPLACED THE INSTRUMENT. THE PROCEDURE WAS COMPLETED WITH NO DELAY AND THE HOSPITAL REPORTED THERE WAS NO INJURY TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117127 BOWEL GRASPER FORCEPS INSERT BOWEL GRASPER FCL KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY 33310G GB

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR