BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 2192720 · Received August 5, 2011

    Report

    Report Number
    3005992282-2011-00169
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 12, 2011
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) = BUCKLE TONGUE WAS CUT THE BAND/BALLOON WITH 60 CM OF CATHETER AND ONE-WAY VALVE WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE SHELL FROM THE BAND WAS CUT AND WAS NOT RETURNED FOR EVALUATION; SECONDLY IT WAS ALSO NOTED THAT BUCKLE TONGUE WAS CUT. A LEAK TEST WAS PERFORMED ON THE BALLOON WITH AN UNSUCCESSFUL RESULT, AND LEAK WAS FOUND. THREE (3) TEARS ON THE BALLOON WERE OBSERVED. THE COMPLAINT CANNOT BE CONFIRMED, DUE TO THE CONDITION IN WHICH IT WAS RETURNED. WHILE IT IS NOT POSSIBLE TO PROVIDE A DEFINITIVE RESULT FOR THE REPORTED EVENT, A REVIEW OF PRODUCT'S INSTRUCTION FOR USE (IFU) WAS PERFORMED, AND IT WAS NOTED THAT THE CURVED BAND IS DESIGNED TO BE OPENED AND RELOCKED IN CASE A MALPOSITION. DETAILED INFORMATION IS PROVIDED WITHIN THE IFU TO UNLOCKED AND RELOCKED THE BAND. HOWEVER, THE SURGEON INDICATED THAT HE COULD NOT UNLOCK THE BAND AND THEREFORE, IT WAS THE SURGEON'S JUDGMENT TO CUT THE BAND INSTEAD. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REALIZE GASTRIC BAND PROCEDURE, WHEN THE SURGEON CLOSED THE INTERLOCK TAB IT WAS TOO TIGHT AND HE COULD NOT LOOSEN IT TO ADJUST IT. HE HAD TO CUT THE BAND TO REMOVE IT AND REPLACE IT WITH A NEW ONE. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1