BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND

    MDR report key: 1954429 · Received January 10, 2011

    Report

    Report Number
    3005992282-2011-00009
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 20, 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). HOOK AND ACTUATOR RING DAMAGED. THE INJECTION PORT WITH THE LOCKING CONNECTOR, TUBING STRAIN RELIEF AND 3.5CM OF CATHETER WERE RETURNED FOR EVALUATION. PER VISUAL INSPECTION, IT WAS OBSERVED THAT THE ACTUATOR RING WAS IN LOCKED POSITION, HOOKS WERE DEPLOYED. THE LOCKING CONNECTOR WAS IN LOCKED POSITION. BIOLOGICAL DEBRIS WAS OBSERVED INSIDE OF THE ACTUATOR RING AND HOOKS. LIQUID WAS STILL INSIDE OF THE SEPTUM RETAINER. PER MICROSCOPIC INSPECTION, IT WAS OBSERVED THAT THE SEPTUM WAS PUNCTURED 1 TIME. A FUNCTIONAL TEST WAS PERFORMED ON THE INJECTION PORT WITH AN UNSUCCESSFUL RESULT. ONE HOOK REMAINED DEPLOYED WHEN THE ACTUATOR RING WAS IN THE UNLOCKED POSITION. IT WAS OBSERVED THAT THE TIP OF THE HOOK WAS ALSO BENT. THE INJECTION PORT WAS DISASSEMBLED AND IT WAS OBSERVED THAT THE LINK WAS NO LONGER ATTACHED TO HOOK AND THE LINK WAS BENT. THE INJECTION PORT MAY HAVE NOT BEEN CORRECTLY SECURED WITH THE REALIZE APPLIER OR WITH ADDITIONAL SUTURES, AS SPECIFIED IN THE INSTRUCTION FOR USE (IFU). ALTERNATIVELY, FAILURE TO PLACE THE PORT IN AN APPROPRIATE LOCATION MAY ENHANCE RISK OF PORT PLACEMENT ISSUE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE RECORDED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE MANUFACTURER PROCESS WAS PERFORMED AND IT WAS NOTED THAT 100% FUNCTIONALLY TESTED IS DONE ON THE INJECTION PORTS ARE PRIOR RELEASE. THEREFORE IT IS UNLIKELY THAT A MANUFACTURE IS CONTRIBUTED AT THIS EVENT DESCRIPTION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST IMPLANT TO A LAPAROSCOPIC ADJUSTABLE GASTRIC BAND PROCEDURE, IT WAS NOTICED THAT THE PORT HAD FLIPPED DURING A ROUTINE ADJUSTMENT. THE ORIGINAL IMPLANT DATE AND SURGEON ARE UNKNOWN. THE PORT WAS REPLACED ON (B)(6) 2010 AND SUTURES WERE USED TO SECURE IN PLACE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1