BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TABLE, OPERATING-ROOM, ELECTRICAL

    MDR report key: 6010493 · Received October 7, 2016

    Report

    Report Number
    6010493
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    July 22, 2016
    Report Date
    September 27, 2016
    Manufacturer
    SMITH AND NEPHEW INC. ENDOSCOPY DIVISION
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AFTER PREPPING AND DRAPING THE PATIENT FOR SURGERY WE TRIED TO ATTACH THE PATIENT'S ARM TO THE SPIDER ARM HOLDER. THE SPIDER MALFUNCTIONED AND WOULD NOT LOCK INTO PLACE TO HOLD THE OPERATIVE ARM FOR THE SURGICAL CASE. MANUFACTURER RESPONSE FOR POSITIONER, SMITH AND NEPHEW (PER SITE REPORTER): WE SENT IT IN ON AN EXCHANGE PROGRAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663251 TABLE, OPERATING-ROOM, ELECTRICAL TABLE, OPERATING-ROOM, ELECTRICAL GDC SMITH AND NEPHEW INC. ENDOSCOPY DIVISION 7615 SPIDER2

    Patients

    Seq Age Sex Outcome Treatment
    1