BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 3170600 · Received June 14, 2013

    Report

    Report Number
    3005992282-2013-00046
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 21, 2013
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAND WAS RETURNED FOR ANALYSIS. PER VISUAL INSPECTION, IT WAS OBSERVED THAT ONE SIDE OF THE BUCKLE WAS RETURNED TORN, IT WAS ALSO NOTED THAT THE BUCKLE TAB AND TONGUE WERE DAMAGED. AS DESCRIBED IN THE EVENT A NEEDLE HOLDER WAS USED AND THERE WAS DIFFICULTY IN PASSING THE GASTRIC BAND THROUGH RETRO GASTRIC TUNNEL THEREFORE EXCESSIVE FORCE MAY HAVE BEEN USED. THIS COULD LEAD TO LEAD TO HTE BAND DAMAGE OBSERVED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND WITH RESPECT TO THE MANUFACTURING PROCESS. IT WAS ALSO NOTED THAT PRODUCTS ARE 100% INSPECTED PRIOR TO DISTRIBUTION, THEREFORE IT IS UNLIKELY THAT A MANUFACTURING ISSUE CONTRIBUTED TO THIS ISSUE.A REVIEW OF THE PRODUCT¿S INSTRUCTION FOR USE (IFU) WAS PERFORMED, AND IT IS NOTED THAT AN ARTICULATING BLUNT DISSECTOR HAVE TO BE USED TO PLACE THE GASTRIC BAND THROUGH THE RETROGASTRIC TUNNEL, IT WAS ALSO NOTED THAT IF EXCESSIVE RESISTANCE IS NOTED, ADDITIONAL DISSECTION OF THE TISSUE CAN BE REQUESTED. ALL INFORMATION ARE PROVIDED WITHIN THE IFU TO PERFORM PLACEMENT OF THE BAND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ASSISTED GASTRIC BYPASS PROCEDURE, THE SURGEON TRIED TO PASS THE SAGB VC THROUGH A RETRO GASTRIC TUNNEL USING A NEEDLE HOLDER. STATING THAT THE PASSAGE WAS A BIT HARDER THAN THE USUAL AND A TEAR IN THE LOCKING BUCKLE APPEARED WHILE PULLING THE DEVICE. THE SURGEON REPLACED THE SAGB IN A NEW SAGB VC, AND THE PATIENT WAS DISCHARGED WITHOUT ANY CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271345 GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZPBBC5

    Patients

    Seq Age Sex Outcome Treatment
    1