BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAMPINE (AMATECH ACCESSORY)

    MDR report key: 171939 · Received June 4, 1998

    Report

    Report Number
    171939
    Event Type
    Malfunction
    Date Received
    June 4, 1998
    Date of Event
    May 8, 1998
    Report Date
    May 20, 1998
    Manufacturer
    MDT DIAGNOSTIC COMPANY
    Product Code
    EYD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING PREPARATION FOR SURGERY THE PT WAS PLACED ON THE SURGICAL TABLE IN THE DORSAL LITHOTOMY POSITION. THE PT'S LEGS WERE PLACED IN THE SURGICAL TABLE ACCESSORY KNEE CRUTCH STIR-UPS. DURING PREPARATION THE RIGHT CLAMP SECURING THE STIR-UP WHICH HELD THE PT'S RIGHT LEG BROKE INTO TWO PIECES. THE OR NURSE REPORTING THE INCIDENT INDICATED SHE HEARD A POP AND THE STIR-UP CLAMP BROKE AND THE PT'S LEG FELL ONTO THE SURGICAL OPERATING TABLE. THE OR NURSE IMMEDIATELY LIFTED THE PT'S LEG AND REPOSITIONED A NEW CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHAMPINE (AMATECH ACCESSORY) SURGICAL TABLE ACCESSORY STIR-UP CLAMP EYD MDT DIAGNOSTIC COMPANY * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR