BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKEFLOW2 WITHOUT TIP (6BX)

    MDR report key: 1820973 · Received August 27, 2010

    Report

    Report Number
    2648666-2010-00369
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 13, 2010
    Manufacturer
    STRYKER ENDOSCOPY PUERTO RICO
    Product Code
    GCX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BROWN LIQUID LEAKED FROM THE BOTTOM OF THE BATTERY HOLE OF THE UNIT. IT WAS FURTHER REPORTED THAT THE SURGEON NOTICED THE PROBLEM AS THE PROCEDURE WAS ENDING. HE DID NOT USE A SPARE AND COMPLETED THE PROCEDURE WITH THE UNIT. IT WAS NOTICED THAT THE BROWN LIQUID SMELLED BURNT AND THE BATTERY WAS HOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKEFLOW2 WITHOUT TIP (6BX) SUCTION/IRRIGATION GCX STRYKER ENDOSCOPY PUERTO RICO 10110FG2

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK