BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1931335 · Received December 17, 2010

    Report

    Report Number
    3005992282-2010-00451
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 10, 2010
    Report Date
    December 13, 2010
    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). THE VELOCITY PORT AND LOCKING CONNECTOR WERE RETURNED. BIOLOGICAL DEBRIS WAS AROUND THE HOOKS AND PORT MECHANISM. THE LOCKING CONNECTOR WAS CORRECTLY CONNECTED TO THE PORT. THE ACTUATOR RING WAS ON LOCKED POSITION WITH HOOKS DEPLOYED. THE SEPTUM RETAINER AND THE LOCKING CONNECTOR MET ALL SPECIFICATIONS. THE PORT DEPLOYED AND RETRACTED HOOKS AS INTENDED USING A SAMPLE PORT APPLIER. THE COMPLAINT CANNOT BE CONFIRMED, THE PORT AND THE LOCKING CONNECTOR MET SPECIFICATIONS. THE TUBING STRAIN RELIEF WAS NOT RETURNED FOR INVESTIGATION. TO MITIGATE THE STRAIN RELIEF "MIGRATION" FROM THE LOCKING CONNECTOR, A DESIGN ENHANCEMENT HAS BEEN IMPLEMENTED WITH THE APPROVAL OF THE FDA TO GLUE THE STRAIN RELIEF TO THE LOCKING CONNECTOR. IN ADDITION, A VOLUNTARY RECALL OF SWEDISH ADJUSTABLE GASTRIC BAND AND REALIZE ADJUSTABLE GASTRIC BANDING PRODUCTS WITH THE PRE-ENHANCEMENT DESIGN WAS INITIATED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-OP A LAPAROSCOPIC ADJUSTABLE BAND PROCEDURE, THE DEVICE'S TUBING CAME OFF AND WAS FOUND BY A GYN SURGEON WHO WAS PERFORMING A LOWER QUADRANT EXPLORATORY LAPAROSCOPY DUE TO PAIN EXPERIENCED BY THE PATIENT FOR A COUPLE OF MONTHS. THE BARIATRIC SURGEON CAME INTO THE CASE AND REPLACED THE PORT. IT WAS UNKNOWN HOW MANY FILLS THE PATIENT HAD, BUT IT WAS NOTED THAT THERE WAS PINK FLUID IN THE TUBING, BUT COMPLETELY OFF AND FLOATING AROUND.

    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 ZJNBB8

    Patients

    Seq Age Sex Outcome Treatment
    1