BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGID OPTICAL STONE CRUSHING FORCEP 30 DEGREE

    MDR report key: 2231222 · Received July 25, 2011

    Report

    Report Number
    2936485-2011-00522
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON FIRST USE OF THE UNIT DURING SURGERY, IT BROKE. IT WAS FURTHER REPORTED THAT THERE WAS NO DELAY IN THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGID OPTICAL STONE CRUSHING FORCEP 30 DEGREE FORCEP GEI STRYKER ENDOSCOPY SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK