BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWEDISH ADJUSTABLE GASTRIC BAND

    MDR report key: 2931536 · Received January 28, 2013

    Report

    Report Number
    3005992282-2013-00009
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    November 5, 2012
    Report Date
    January 9, 2013
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION RECEIVED:WHAT SIZE TROCAR WAS THE BAND PLACED THROUGH ? 15MM.DOES SURGEON FEEL ANY DIFFICULTIES WITH BAND PLACEMENT? NO.HOW MANY ADJUSTMENTS HAD RECEIVED THE PATIENT ? UNKNOWN.HAS THEIR BEEN ANY DIFFICULTIES WITH ADJUSTMENT/FILLS ? NO.HOW DID THE PATIENT PRESENT WHEN THE PROBLEM WAS IDENTIFIED? WEIGHT GAIN, NO RESTRICTION OF INTAKE OF FOOD ANYMORE.

    Additional Manufacturer Narrative · 1

    (B)(4). REINFORCEMENT BAND DAMAGED VISUAL EXAMINATION THE (B)(4) ADJUSTABLE GASTRIC BAND CONFIRMED THAT THE BAND WAS TORN AT THE TAB ADJACENT TO THE POINT OF CATHETER CONNECTION TO THE BALLOON. AN ENGINEERING STUDY HAS BEEN PERFORMED WITH THE INTENT TO ESTABLISH ROOT CAUSE FOR REINFORCING BAND TAB DAMAGE ON SIMILAR PRODUCT. IT WAS CONCLUDED THAT THE OBSERVED FAILURE MODE WAS CONSISTENT WITH HIGH STRESS GRADIENTS OBSERVED AT THE POINT OF BREAKAGE. THE REPORT TENTATIVELY CONCLUDED THAT BALLOON OVER-FILLING WAS A POSSIBLE CONTRIBUTOR TO SUCH HIGH STRESS GRADIENTS. HOWEVER, THIS COULD NOT BE DEFINITIVELY CONFIRMED WITHIN THE STUDY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE CONTROLS A DEFECT OF THE GASTRIC BAND WAS OBSERVED SEVEN YEARS AFTER IMPLANTATION OF THE BAND. IN A SURGICAL PROCEDURE THE DAMAGED GASTRIC BAND WAS REMOVED AND A NEW BAND HAS BEEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36801 SWEDISH ADJUSTABLE GASTRIC BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK 0310057

    Patients

    Seq Age Sex Outcome Treatment
    1