BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SM PLUS BTT/ROUND BALLOON DISSECTOR

    MDR report key: 6167818 · Received December 12, 2016

    Report

    Report Number
    2647580-2016-01067
    Event Type
    Injury
    Date Received
    December 12, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 15, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K042412
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AND AN EVALUATION OF THE RETURNED DEVICE. FUNCTIONALLY, THE TROCAR BALLOON AND THE DISSECTOR BALLOON WERE INFLATED AND DID NOT DEMONSTRATE ANY LEAKS. VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE CONFIRMED THE PRODUCT MET QUALITY RELEASE SPECIFICATIONS THAT WERE TESTED REGARDING. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REFERENCE NUMBER: (B)(4). DEVICE RECEIVED FOR EVALUATION; DEVICE EVALUATION PENDING; DEVICE IDENTIFICATION AND MANUFACTURING NUMBERS; (B)(4).

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A BILATERAL INGUINAL HERNIA REPAIR THE DISSECTOR BALLOON WOULD NOT STAY INFLATED WHILST CAMERA WAS INSERTED INTO PORT. THE GAS VALVE ON THE BODY OF THE DEVICE WAS NOT WORKING AND MAKING A "HISSING SOUND". PATIENT WAS NOT HARMED DUE TO THE FAULTY DEVICE, ALTHOUGH THE SURGEON DID HAVE TO CHANGE THE PROCEDURE FROM LAPAROSCOPIC TO OPEN DUE TO THE MULTIPLE PROBLEMS WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    818059 SM PLUS BTT/ROUND BALLOON DISSECTOR LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC SMBTTRND P6G0722X

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention