BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTIGE ATRAUMATIC

    MDR report key: 3212302 · Received July 2, 2013

    Report

    Report Number
    3212302
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    February 21, 2013
    Report Date
    July 2, 2013
    Manufacturer
    AESCULAP AG
    Product Code
    CCW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PROCEDURE STARTED AND SURGEON STATED THAT THE GRASPER "JUST BROKE", JAW FELL OFF. NO PATIENT INJURY. PIECE WAS LOCATED AND REMOVED FROM THE OPERATIVE FIELD. A NEW DEVICE WAS OBTAINED AND THE CASE CONTINUED. UNEVENTFUL SURGERY.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LAPAROSCOPIC NEPHRECTOMY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302961 PRESTIGE ATRAUMATIC LAPAROSCOPE, GENERAL & PLASTIC SURGERY CCW AESCULAP AG * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR SURGICAL INSTRUMENTS LAPAROSCOPIC