BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGB QUICK CLOSE

    MDR report key: 1770644 · Received July 27, 2010

    Report

    Report Number
    3005992282-2010-00218
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    February 3, 2010
    Report Date
    April 7, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAND WAS RETURNED WITH THE BUCKLE TORN FROM THE BAND. FOLDLINES WERE ALSO PRESENT ON THE BAND. THE BAND WAS LEAKED TEST AND NO LEAKS FOUND. IT IS NOTED THAT THE PRODUCT'S INSTRUCTION FOR USE (IFU) CAUTIONS AGAINST DAMAGING ANY PART OF THE BAND. AN ENGINEERING STUDY HAS BEEN PERFORMED TO TRY AND REPLICATE THE DAMAGE SEEN AT THE BUCKLE AREA AND IT IS NOTED THAT THIS FAILURE MODE COULD NOT BE REPLICATED WITHOUT PRIOR DAMAGE TO THE BAND BY A SHARP INSTRUMENT. IT IS THEREFORE TENTATIVELY SUGGESTED THAT THE REPORTED EVENT COULD BE THE RESULT OF INADVERTENT DAMAGE TO THE BAND AT THE TIME OF IMPLANT, ULTIMATELY RESULTING IN THE BUCKLE DAMAGE OBSERVED, HOWEVER, THIS CANNOT BE CONFIRMED. IT IS ALSO NOTED THAT THE DAMAGE OBSERVED TO THE BUCKLE WILL HAVE CONTRIBUTED TO THE REPORTED EVENT OF FAILURE TO LOSE WEIGHT. A DHR-REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS COMMUNICATED. IT IS UNLIKELY THAT A MANUFACTURING ISSUE CONTRIBUTED TO THE REPORTED EVENT. ALL DEVICES ARE 100% VISUALLY INSPECTED PRIOR TO RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE GASTRIC BAND WAS REMOVED DUE TO POOR WEIGHT LOSS. THE SAGB PARTIALLY DISINTEGRATED DURING REMOVAL BY THE SURGEON. HE HAS ASKED FOR IT TO BE TESTED FOR QA. A REINSERTION OF A NEW SAGB WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAGB QUICK CLOSE IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR