BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM, 33CM HOOK SCISSORS

    MDR report key: 1732199 · Received June 2, 2010

    Report

    Report Number
    2936485-2010-00458
    Event Type
    Malfunction
    Date Received
    June 2, 2010
    Date of Event
    May 25, 2010
    Report Date
    May 25, 2010
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    HRR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED. A SIMILAR PRODUCT FROM LOT # 842267 WAS ALSO IMPLICATED IN THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT NEEDS TO BE SHARPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM, 33CM HOOK SCISSORS SCISSORS HRR STRYKER ENDOSCOPY SAN JOSE 842263

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK