BEUDAMED
    FDA Adverse Event Other Summary report: N

    SERVICE REP, A'SCOPE, A'CLAV

    MDR report key: 653919 · Received September 20, 2005

    Report

    Report Number
    1216828-2005-00034
    Event Type
    Other
    Date Received
    September 20, 2005
    Date of Event
    August 18, 2005
    Report Date
    September 19, 2005
    Manufacturer
    SMITH & NEPHEW, INC. - ENDOSCOPY DIVISION
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING KNEE ARTHROSCOPY PROCEDURE, THE DOCTOR HAD TO CANCEL THE CASE. AFTER STEAM STERILIZATION OF THE SCOPE, IT WAS HOOKED UP TO THE CAMERA AND DISCOVERED THAT THE SCOPE WAS EXTREMELY CLOUDY. THE PATIENT WAS ON THE O.R. TABLE UNDER SEDATION WHEN THEY CANCELLED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVICE REP, A'SCOPE, A'CLAV * HRX SMITH & NEPHEW, INC. - ENDOSCOPY DIVISION 3894S *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other