BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MMX 45CM STRYKEPROBE L-TIP

    MDR report key: 1991322 · Received January 25, 2011

    Report

    Report Number
    2936485-2011-00043
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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 DURING A CASE, THE L HOOK ON THE UNIT BROKE OFF. IT WAS FURTHER REPORTED THAT IT APPEARED THE WELD ON THE UNIT HAD COMPLETELY BROKEN OFF. NOTHING WAS LOST IN THE PATIENT AND THE CASE WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MMX 45CM STRYKEPROBE L-TIP ELECROSURGICAL GEI STRYKER ENDOSCOPY SAN JOSE 10G0168

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK