BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2950294 · Received February 8, 2013

    Report

    Report Number
    3005992282-2013-00012
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 18, 2013
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHAT TYPE OF GRASPER WAS USED WHEN MANIPULATING THE SUTURE GOLD FINGER TO PULL THROUGH SUTURE LOOP. WHAT SIZE TROCAR WAS THE BAND PLACED THROUGH? 15MM. ANY DIFFICULTIES GETTING BAND THROUGH THE TROCAR? NO. ANY DIFFICULTIES WITH BAND PLACEMENT? NO OTHER THAN TRYING TO DEAL WITH BROKEN SUTURE AND HAVING TO RE-TIE THE CURVED BAND/BALLOON WITH 60CM OF CATHETER AND ONE WAY VALVE WERE RETURNED FOR EVALUATION. THE SUTURE PART WAS NOT RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE BUCKLE WAS RETURNED TORN ON THE SNORKEL SIDE, AND THAT SEVERAL BLACK STAINES WERE OBSERVED ON BALLOON AND REINFORCING BAND. WHILE IT IS NOT POSSIBLE TO PROVIDE A DEFINITIVE RESULT FOR THE REPORTED EVENT IT IS TENTATIVELY SUGGESTED THAT THE DEVICE WAS INADVERTENTLY NICKED/DAMAGED DURING MANIPULATION AROUND THE BUCKLE. THIS MAY IN TURN HAVE CAUSED THE BUCKLE TO TEAR AFTER BAND PLACEMENT PROCEDURE. REVIEW OF THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) INDICATES THAT THE IFU CAUTIONS AGAINST DAMAGING ANY PART OF THE BAND, IT IS ALSO NOTED THAT DETAILED INSTRUCTIONS REGARDING PROPER DEVICE MANIPULATION TECHNIQUE ARE PROVIDED. A DEVICE HISTORY RECORD 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 A MANUFACTURING ISSUE IS UNLIKELY TO HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ADJUSTABLE BAND PROCEDURE, THE SUTURE LOOP BROKE IN HALF THEN THE SURGEON TRIED TO RETIE THE SUTURE LOOP AND WAS TIED HOWEVER WHEN LATCHING THE BUCKLE THE BUCKLE BROKE. NO PIECES FELL INTO THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54915 REALIZE ADJ GASTRIC BAND-C IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ZLLBD2

    Patients

    Seq Age Sex Outcome Treatment
    1