BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TOMCAT CUTTER, FORMULA (5BX)

    MDR report key: 2945350 · Received December 27, 2012

    Report

    Report Number
    2648666-2012-00393
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    PMA / PMN Number
    K941333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ROTATING BLADE BROKE OFF DURING SURGERY. ALLEGEDLY, THE SURGEON WAS ABLE TO RETRIEVE THE PIECE COMPLETE WITH AN ALLIGATOR ARTHROSCOPIC FORCEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM TOMCAT CUTTER, FORMULA (5BX) HRX STRYKER ENDOSCOPY PUERTO RICO 12061CE2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK