BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3908502 · Received June 17, 2014

    Report

    Report Number
    3908502
    Event Type
    Malfunction
    Date Received
    June 17, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 13, 2014
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FIRST DEVICE POPPED/SNAPPED WHEN ACTIVATED, 2ND DEVICE OPENED HAD EXPOSED WIRES AND COILED WIRES, 3RD DEVICE OPENED WORKED WELL. MULTIPLE DEVICE FAILURES-ADDITIONAL OR TIME, NO PATIENT HARM. ALL THREE DEVICES HAD THE SAME LOT #. EXPIRATION DATES ARE NOT ON AVAILABLE.======================MANUFACTURER RESPONSE FOR STORZ SUPRALOOP, BRUCKER/MESSROGHLI (PER SITE REPORTER).======================REP--BY EMAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355936 * ELECTROSURGICAL, CUTTING AND COAGULATION GEI KARL STORZ ENDOSCOPY-AMERICA, INC * 46615
    355937 * ELECTROSURGICAL, CUTTING AND COAGULATION GEI KARL STORZ ENDOSCOPY-AMERICA, INC * 46615

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR