BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM MONOPOLAR HANDLE 33CM

    MDR report key: 6040506 · Received October 19, 2016

    Report

    Report Number
    0002936485-2016-00977
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    September 26, 2016
    Report Date
    September 26, 2016
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    OCZ
    PMA / PMN Number
    K973259
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR INVESTIGATION AND THE REPORTED FAILURE MODE WAS CONFIRMED. THE FAILURE MODE WILL BE MONITORED FOR FUTURE REOCCURRENCE. ALLEGED FAILURE: CHIPPING. CONFIRMED FAILURE: COATING PEELING OFF HANDLE. PROBABLE ROOT CAUSE: POOR AUTOCLAVE RELIABILITY, INCORRECT STERILIZATION/REPROCESSING PROCEDURE, HANDLING PROCEDURES, CONTACT FORCES, PRODUCT USED BEYOND DEFINED USEFUL LIFE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULATION HAD BEEN COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692149 5MM MONOPOLAR HANDLE 33CM ENDOSCOPIC GRASPING/CUTTING INSTRUMENT, NON-POWERED OCZ STRYKER ENDOSCOPY-SAN JOSE ¿1147156D¿

    Patients

    Seq Age Sex Outcome Treatment
    1