BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA

    MDR report key: 1840970 · Received September 22, 2010

    Report

    Report Number
    3005992282-2010-00275
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAND/BALLOON WITH 60CM OF CATHETER AND THE ON-WAY VALVE WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BUCKLE WAS TORN ON THE SNORKEL SIDE (STRAIN RELIEF). SEVERAL BLACK AND BROWN STAINS WERE OBSERVED ON THE BAND AND BALLOON. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS IN RELATION TO THE ALLEGED ISSUE.

    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 BANDING PROCEDURE, THE SURGEON WAS IN THE PROCESS OF INTRODUCING THE CLOSING MECHANISM THROUGH THE CLASP OF THE BELT WHEN THE MATERIAL OF THE CLASP TORE DOWN ONE SIDE. THE WAS NO EXCESSIVE FORCE APPLIED TO THE BAND. THE CLASP HAD COMPLETELY SHEARED DOWN ONE SIDE AND HAD TO BE DISCARDED. THE PROCEDURE WAS PROLONGED 15 MINUTES. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEN2 ADJUSTABLE GASTRIC BAND - 11 CM, UNLOCKA IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK 20204443

    Patients

    Seq Age Sex Outcome Treatment
    1