BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAGB VELOCITY CURVED BAND

    MDR report key: 3981580 · Received August 5, 2014

    Report

    Report Number
    3005992282-2014-00046
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    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). ADDITIONAL INFORMATION: ONE CURVED ADJUSTABLE GASTRIC BAND WAS RETURNED WITH THE PACKAGING LABEL, PORT APPLIER, BALLOON WITH THE EXTENDER STRAP INCLUDING THE BLACK CUTTING INDICATOR & STILL ATTACHED AND A CUT ALONG ONE ARM OF THE BUCKLE. THE PORT, RED SAFETY CAP, LOCKING CONNECTOR, AND ADDITIONAL EXTENDER STRAP WHICH HAS A TEAR / A MISSING CHUNK OF SILICONE WERE ALSO RETURNED. NO FUNCTIONAL TESTS WERE PERFORMED AS EVENT DESCRIPTION ALLEGED A TEAR ALONG THE BUCKLE ONLY. THE COMPLAINT IS CONFIRMED. THE TEAR ALONG THE BUCKLE IS NOT A CLEAN CUT. A CLEAN CUT WOULD INSINUATE A SHARP INSTRUMENT HAD CAUSED THE TEAR. NO DEFINITIVE ROOT CAUSE CAN BE ATTRIBUTED HERE. HOWEVER AS PER IFU THE USE OF FORCE WHILST INSERTING THE BAND, USING EITHER THE PUSH OR PULL METHOD, MAY RESULT IN THIS TYPE OF FAILURE. A REVIEW OF THE IFU WAS CARRIED OUT AND IT IS CLEARLY INDICATED THAT CARE AND ATTENTION NEEDS TO BE PAID WHEN INSERTING THE BAND TO AVOID BAND DAMAGE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND WITH RESPECT TO THE MANUFACTURING PROCESS. IT WAS ALSO NOTED THAT PRODUCTS ARE 100% INSPECTED PRIOR TO DISTRIBUTION, THEREFORE IT IS UNLIKELY THAT A MANUFACTURING ISSUE CONTRIBUTED TO THIS ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC BAND PROCEDURE, THE SURGEON, PLACED THE BAND INSIDE THE PATIENT. AS HE WAS POSITIONING IT, HE NOTICED THAT PART OF THE BUCKLE MECHANISM WAS TORN. HE DOES NOT BELIEVE IT WAS DUE TO PLACING IT DOWN THE TROCAR AS NO RESISTANCE WAS FELT WHEN INSERTING IT. HE REMOVED THE BAND AND OPENED ANOTHER ONE, WHICH WAS PLACED WITHOUT ISSUE. THERE WAS LESS THAN FIVE MINUTES TIME ADDED TO THE PROCEDURE AND NO ADVERSE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457154 SAGB VELOCITY CURVED BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ NA ZNNBB6

    Patients

    Seq Age Sex Outcome Treatment
    1