BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1822906 · Received September 1, 2010

    Report

    Report Number
    3005992282-2010-00260
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 9, 2010
    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): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). BENT HOOKS THE VELOCITY PORT WAS RETURNED FOR ANALYSIS. PER VISUAL INSPECTION, THE PORT WAS RETURNED CLEAN. THE ACTUATOR RING WAS IN THE LOCKED POSITION WITH FOUR (4) HOOKS DEPLOYED. THE SEPTUM RETAINER MEASUREMENT: 2.79MM DIAMETER. A LEAK TEST AND BLOCKAGE TEST WERE PERFORMED WITH SUCCESSFUL RESULTS. A FUNCTIONAL TEST WAS PERFORMED WITH UNSUCCESSFUL RESULT. HOOKS CANNOT BE RETRACTED. THE PORT MECHANISM WAS BLOCKED. THE PORT WAS DISMANTLED, AND IT WAS OBSERVED THAT TWO (2) HOOKS WERE BENT. A POTENTIAL CAUSE OF THE INVESTIGATION FINDINGS, IS THAT DURING THE PROCEDURE THE PORT WAS INADVERTENTLY PLACED ON A BONY STRUCTURE WHICH COULD HAVE CAUSED HOOKS TO BEND. A REVIEW OF MANUFACTURING RECORDS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND MET ALL RELEASE CRITERIA. ALL PORTS ARE VISUALLY AND MECHANICALLY INSPECTED PRIOR TO RELEASE AND DAMAGED HOOKS WOULD HAVE BEEN IDENTIFIED DURING THIS PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT DURING A LAPAROSCOPIC ADJUSTABLE BAND PROCEDURE, THE PORT WOULD NOT DEPLOY THEN FAILED TO UN-DEPLOY. ONE OF THE HOOKS WOULD NOT DEPLOY TO PLACE THE PORT INTO THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES 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 ZLGBCH

    Patients

    Seq Age Sex Outcome Treatment
    1