BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 4140861 · Received October 3, 2014

    Report

    Report Number
    3005992282-2014-00055
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: PORT APPLIER, PORT & RED CAP IN UNOPENED PACKAGING AND BAND WITH FULL CATHETER ATTACHED WAS RETURNED. THE LOT NUMBER ETCHED ON THE BAND IS ZRCBBD. THE COMPLAINT ALLEGES BALLOON LEAKAGE. LEAK TEST PERFORMED AND THE PRODUCT FAILED THE TEST. A LEAK WAS EVIDENT ON THE BAND. THERE IS A MINUTE HOLE VISIBLE ON THE BAND. THIS IS A CLEAN CUT HOLE, NOT A TEAR, WHICH MAY SUGGEST NEEDLE / SHARP OBJECT PERFORATION. A DEVICE HISTORY RECORDS (DHR) REVIEW WAS CARRIED OUT AND NO DISCREPANCIES IN RELATION TO THIS EVENT WERE NOTED ON THE FILE. A REVIEW OF THE MANUFACTURING PROCESS WAS PERFORMED AND IT IS NOTED THAT ALL PRODUCTS ARE 100% LEAK TESTED PRIOR TO RELEASE; THEREFORE IT IS UNLIKELY THAT A MANUFACTURING ISSUE CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE OF THE DEVICE IN A GASTRIC BANDING PROCEDURE, WHEN THE SCRUB NURSE PRE-TESTED THE DEVICE (PUT BAND IN BOWL OF WATER), SOME BUBBLES CAME OUT AND THERE WAS ONE LITTLE HOLE IN THE BAND. A NEW DEVICE WAS OPENED AND USED INSTEAD. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619716 GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZRFBBK

    Patients

    Seq Age Sex Outcome Treatment
    1