BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EEA

    MDR report key: 8824545 · Received July 24, 2019

    Report

    Report Number
    1219930-2019-04413
    Event Type
    Malfunction
    Date Received
    July 24, 2019
    Date of Event
    July 9, 2019
    Report Date
    December 9, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521047518
    PMA / PMN Number
    K083781
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    POST MARKET VIGILANCE (PMV) LED A PHOTOGRAPHIC EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION NOTED: THE PRESENCE OF A HEMORRHOID STAPLER AND AN ANVIL. THE SAFETY IS ENGAGED AND THERE APPEARS TO BE NO PORT, ANOSCOPE, OR DILATOR. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. THE INVESTIGATION CONCLUDED THERE WERE NO ABNORMALITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH REGARD TO THE REPORTED CONDITIONS. THE INFORMATION FOR USE BOOKLET WARNS THE USER THAT WHEN OPENING THE STAPLER, PRIOR TO REMOVAL, NOT TO TURN THE TWIST KNOB MORE THAN TWO FULL TURNS, AS THIS MAY ALLOW THE ANVIL ASSEMBLY TO SEPARATE FROM THE INSTRUMENT. WITHOUT THE PHYSICAL PRODUCT, A DEFINITIVE ROOT CAUSE COULD NOT BE IDENTIFIED. POST MARKET VIGILANCE WILL CONTINUE TO MONITOR THIS CONDITION FOR FUTURE POTENTIAL ACTION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, PRE OPERATIVELY, ON A STAPLED HEMORRHOIDOPEXY (LONGO PROCEDURE), WHILE ON PREPARATION, THE DEVICE WAS DIFFICULT OR UNABLE TO LOAD AND THE ANVIL DISENGAGED AND DID NOT FALL ON THE PATIENT¿S CAVITY. THEY USED ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616723 EEA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN HEM3335 N8M0279MY 10884521047518

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR