BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKLINE

    MDR report key: 6208286 · Received December 28, 2016

    Report

    Report Number
    6208286
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    December 16, 2016
    Report Date
    December 22, 2016
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A CASE, THE LAPAROSCOPIC BOWEL GRASPER BROKE WHILE IN USE. ONE OF THE BLADES BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED BY THE GENERAL SURGEON. THE ENDO INSTRUMENT MANAGER CAME INTO OR AND VERIFIED THAT ALL OF THE PIECES WERE PRESENT AND THAT NOTHING WAS LEFT INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860453 CLICKLINE ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI KARL STORZ ENDOSCOPY-AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR