BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5 MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)

    MDR report key: 1911279 · Received November 22, 2010

    Report

    Report Number
    2648666-2010-00463
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 5, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    HRX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT LOCKED UP DURING A SHOULDER PROCEDURE. THE UNIT SPUN 3 TIMES AND SEIZED, WITH THE INNER TEETH LOCKING UP AGAINST THE OUTER TEETH OF THE SHEATH. IT WAS FURTHER REPORTED THAT METAL SHARDS FROM THE UNIT WERE LEFT IN THE SHOULDER OF THE PT. ANOTHER UNIT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK