BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOCONTROL ARTHROSCOPY PUMP

    MDR report key: 4132967 · Received October 1, 2014

    Report

    Report Number
    0002936485-2014-00772
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ENDOSCOPY-SAN JOSE
    Product Code
    HRX
    PMA / PMN Number
    K030402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS RETURNED, BUT THE FAILURE MODE WAS NOT CONFIRMED. VISUAL INSPECTION- THERE ARE NO INDICATIONS FOR TRANSPORT DAMAGE OR MISUSE. THE VISUAL INSPECTION PERFORMED FOR THE DEVICE SHOWED THAT THE ROLLER WHEELS ARE WORN. FUNCTIONAL INSPECTION- THE FUNCTIONAL INSPECTION PERFORMED SHOWED THAT THE UNIT IS WORKING ACCORDING TO SPECIFICATION. THE RESULTS OF THE INVESTIGATION PERFORMED INDICATED THAT THE RETURNED UNIT IS WORKING ACCORDING TO SPECIFICATION. ROOT CAUSE(S): THE REPORTED EVENT COULD NOT BE CONFIRMED. THERE ARE NO INDICATIONS FOR A MANUFACTURING ISSUE. FURTHER INVESTIGATION SHOWED THAT THE FAILURE DESCRIPTION WAS MOST LIKELY CAUSED BY DIFFICULTIES DURING USE OF THE DEVICES, POSSIBLY DUE TO THE USER'S UNAWARENESS OF THE EXACT FUNCTIONALITY OF THE DEVICE. IN SUM, THE UNIT WAS RETURNED, BUT THE FAILURE MODE WAS NOT CONFIRMED.

    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 PATIENT'S JOINT WAS SWOLLEN DUE TO OVER PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S JOINT WAS SWOLLEN DUE TO OVER PRESSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612855 FLOCONTROL ARTHROSCOPY PUMP ARTHROSCOPE HRX STRYKER ENDOSCOPY-SAN JOSE

    Patients

    Seq Age Sex Outcome Treatment
    1