BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM 30 AUTOCLAVABLE ARTHROSCOPE

    MDR report key: 2870553 · Received November 14, 2012

    Report

    Report Number
    2936485-2012-00551
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 26, 2012
    Report Date
    September 26, 2012
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K962075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF THE UNIT ON (B)(4)-2012, IT WAS OBSERVED THAT A SMALL METAL PIECE OF THE UNIT IS MISSING AND WE ARE FILING AT THIS TIME. (B)(4). ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT HAS A SHAVED TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM 30 AUTOCLAVABLE ARTHROSCOPE HRX STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK