BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 2990460 · Received March 5, 2013

    Report

    Report Number
    3005992282-2013-00026
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 14, 2013
    Report Date
    February 8, 2013
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ATTEMPTS HAVE BEEN MADE TO HAVE DEVICE RETURNED. DEVICE LOCATION IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). PUNCTURE PER VISUAL INSPECTION, IT WAS OBSERVED THAT THE BALLOON WAS CRACKED NEAR OF THE CATHETER CONNECTION. MICROSCOPIC ANALYSIS SUGGESTS THAT THE TEAR IS THE RESULT OF MANIPULATION OF THE BALLOON WITH A SHARP INSTRUMENT DURING THE IMPLANTATION OR EXPLANATION. THERE WERE NO DISCREPANCIES RECORDED DURING THE MANUFACTURING PROCESS IN RELATION TO THE ALLEGED ISSUE, AND THAT ALL PRODUCTS ARE 100% LEAK TESTED AT A MINIMUM PRIOR TO RELEASE; THEREFORE IT IS UNLIKELY THAT A MANUFACTURING ISSUE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BAND IMPLANT, A LEAK WAS OBSERVED ON THE RING (BAND PERFORATION). ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO CONSEQUENCES FOR THE PATIENT. A 12MM AND 15MM TROCAR WAS USED WHEN INSERTING THE BAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92835 GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZNGBB7

    Patients

    Seq Age Sex Outcome Treatment
    1