BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1911955 · Received December 1, 2010

    Report

    Report Number
    3005992282-2010-00383
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INJECTION PORT WITH LOCKING CONNECTOR AND TUBING STRAIN RELIEF WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE ACTUATOR RING WAS RETURNED IN THE UNLOCKED POSITION, HOOKS WERE RETURNED RETRACTED. PER MICROSCOPE ANALYSIS IT WAS OBSERVED THAT THE SEPTUM WAS PUNCTURED 16 TIMES. NO CRACKS OR PUNCTURES WERE OBSERVED ON THE TUBING STRAIN RELIEF. AS PER THE INFORMATION PROVIDED (I.E. OBSERVATION OF PORT DISCONNECTION) A MEASUREMENT WAS PERFORMED OF THE PORT CONNECTION TUBE AND INNER LOCKING CONNECTOR, WHICH WERE FOUND TO BE WITHIN SPECIFICATION. PRODUCT ANALYSIS CANNOT CONFIRM THE REPORTED EVENT OF PORT DISCONNECTION. 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. OUR INVESTIGATIONS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS AND MET ALL RELEASE CRITERIA. NO RELEVANT DISCREPANCIES WERE NOTED DURING MANUFACTURE OF THE IN BATCH QUESTION. ALL DEVICES ARE INSPECTED PRIOR TO RELEASE. DEVICE WAS RETURNED FULLY FUNCTIONAL.

    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 OF A REALIZE ADJUSTABLE BAND, THE SURGEON WAS NOT ABLE TO ASPIRATE DURING THE ADJUSTMENTS. UNDER FLUOROSCOPY THE RADIOOPAQUE TUBING COULD NOT BE SEEN. THE PORT WAS REMOVED AND REPLACED. THE STRAIN RELIEF WAS IN THE INCISION. THE ORIGINAL BAND REMAINS IN THE PATIENT. THERE ARE NO PATIENT 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

    Patients

    Seq Age Sex Outcome Treatment
    1