BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.4MM GRASPER WITH RATCHET

    MDR report key: 1162276 · Received September 5, 2008

    Report

    Report Number
    2936485-2008-00073
    Event Type
    Malfunction
    Date Received
    September 5, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BO
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT 3.4 MM LOOSE BODY GRASPER WITH RATCHET BROKEN IN TWO PARTS DURING OPERATION. CUSTOMER INFORMED THAT HE IS NOT AWARE WHAT CAUSED THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.4MM GRASPER WITH RATCHET GRASPER HRX STRYKER ENDOSCOPY SAN JOSE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK