BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 1903829 · Received November 20, 2010

    Report

    Report Number
    3005992282-2010-00374
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    April 29, 2010
    Report Date
    November 5, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAND/BALLOON WITH 20CM OF CATHETER WAS RETURNED FOR EVALUATION. EVALUATION OF THE DEVICE CANNOT CONFIRM EVENTS THAT ARE PHYSIOLOGICAL IN NATURE. EROSION IS A RECOGNIZED ADVERSE EVENT ASSOCIATED WITH GASTRIC BANDING AND THE SWEDISH ADJUSTABLE GASTRIC BAND. THE FINAL PACKAGING LOT AND/OR BATCH NUMBER WERE NOT COMMUNICATED, THEREFORE NO DEVICE HISTORY RECORD (DHR) REVIEW CAN BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    SURGICAL TECHNICIAN REPORTS, WHILE TESTING EQUIPMENT PRIOR TO A SURGICAL PROCEDURE, IT WAS NOTED THE 4.5 MM CURVED ARTHROSCOPIC SHAVER WOULD NOT "SPIN." TWO MORE SHAVERS OF THE SAME TYPE AND LOT NUMBER WERE OPENED AND ALSO WOULD NOT WORK PROPERLY. THEY WOULD NOT SPIN EFFECTIVELY WHEN ATTACHED TO THE SURGICAL DRILL. A STRAIGHT SHAVER (SAME MANUFACTURER/DIFFERENT MODEL NUMBER) WAS TESTED AND WORKED APPROPRIATELY. THIS REPLACEMENT SHAVER WAS USED FOR THE REMAINDER OF THE PROCEDURE. ONCE THE PROCEDURE WAS COMPLETE THE SURGICAL TECHNICIAN BAGGED THE SHAVERS WHICH WERE TESTED AND DID NOT WORK. HE ALSO REMOVED 10 MORE SHAVERS FROM THE SAME LOT NUMBER OFF OF OUR SHELVES. PRODUCT HAS BEEN RETAINED IN RISK MANAGEMENT AND WILL BE RETURNED, UPON REQUEST, TO THE MANUFACTURER FOR TESTING PURPOSES. THERE WAS NO INJURY TO THE PATIENT SINCE PRODUCTS NEVER REACHED THE SURGICAL FIELD.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEVICE WOULD NOT TURN AS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT OF A (B)(4) ADJUSTABLE GASTRIC BAND A GASTRIC EROSION WAS OBSERVED AND THAT BAND WAS REMOVED WITH REPORTED PATIENT COMPLICATIONS. ADDITIONAL FOLLOW UP IS BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICK CLOSE IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention