BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT

    MDR report key: 4242364 · Received November 11, 2014

    Report

    Report Number
    3005992282-2014-00062
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    July 30, 2014
    Report Date
    October 31, 2014
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION ASKED FOR BUT UNKNOWN OR NOT PROVIDED DURING INITIAL CONTACT.SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT.RESPONSES RECEIVED FROM ADDITIONAL INFORMATION REQUESTED: WHAT IS THE PATIENTS CURRENT STATUS? ¿ BAND STILL IN PLACE, PORT REVISED AND REPOSITIONED FOR EASIER ACCESS.WAS THE ADJUSTMENT PERFORMED UNDER FLUOROSCOPY? ¿ YES, BAND FILLED AND EMPTIED NORMALLY, BAND AND PORT FULLY FUNCTIONAL.WILL THE BAND BE EXPLANTED? IF SO, WILL THE BAND BE RETURNED FOR EVALUATION? - NOWHAT IS THE LOT NUMBER OF THE PRODUCT? ???HAS THE PORT FLIPPED PREVENTING ACCESS TO THE PORT AND THEREFORE PREVENTING BAND ADJUSTMENT? - NO.HAS A PORT DISCONNECTION BEEN NOTED? ¿ NO.THIS DOES NOT APPEAR TO BE A PRODUCT COMPLAINT, MORE A TECHNICAL ERROR FILLING THE BAND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A GASTRIC BAND PROCEDURE, THE SURGEON HAS BEEN UNABLE TO ADJUST THE BAND. HE HAS TRIED SEVERAL TIMES, INCLUDING INTRA-OPERATIVE INVESTIGATION. PATIENT IS GOING BACK INTO THEATRE ON (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726852 SAGB QUICKCLOSE WITH VELOCITY* INJECTION PORT IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1