BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 2230865 · Received August 26, 2011

    Report

    Report Number
    1037905-2011-00554
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    WILSON-COOK MEDICAL, INC.
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY OUR DISTRIBUTOR IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN (B)(6). (B)(6). (B)(4). EVALUATION: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PROD THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCTS FROM THIS LOT REMAINED IN INVENTORY. CONCLUSIONS: WE COULD NOT CONDUCT A COMPLETE INVESTIGATION BECAUSE THE PROD SAID TO BE INVOLVED WAS NOT RETURNED FOR EVAL. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. HEMORRHAGE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL COMPLICATION ASSOCIATED WITH GASTROINTESTINAL ENDOSCOPY. PRIOR TO DISTRIBUTION, ALL 6 SHOOTER SAEED MULTI-BAND LIGATORS ARE SUBJECTED TO A VISUAL INSPECTION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENT PRIOR TO SHIPMENT. CORRECTIVE ACTION: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. BASED ON THIS REVIEW, THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS. ADD'L COMMENTS REGARDING THIS REPORT: THE INFO PROVIDED IN THIS REPORT WAS REVIEWED BY CLINICAL PERSONNEL. CLINICAL PERSONNEL INDICATED ULCERS AND BLOOD ON THE VARICES ARE EXPECTED AFTER BANDING. BECAUSE THE ENDOSCOPE WAS PLACED INTO THE ESOPHAGUS VERY SOON AFTER BAND PLACEMENT, THIS COULD HAVE CONTRIBUTED TO DETACHMENT OF THE BANDS FROM THE VARICES. SLIPPAGE OF THE BAND FROM THE VARIX CAN OCCUR IF THE ENDOSCOPE IS ADVANCED BEYOND THE BANDED SITE. THE INSTRUCTIONS FOR USE ADVISE THE USER THAT PASSING THE ENDOSCOPE OVER A PREVIOUSLY PLACED BAND MAY DISLODGE THE BAND. BAND DETACHMENT FROM THE VARICES CAN ALSO OCCUR IF THE PT HAS BEEN BANDED OR SCLEROSED AT AN EARLIER DATE. THE CLINICAL PERSONNEL INDICATED IT IS UNCLEAR HOW THE NUMBER OF BANDS PLACED (4 BOXES OF 6 BANDS EACH) COULD BE PLACED IN THE ESOPHAGUS WITHOUT PLACING MULTIPLE BANDS ON EACH VARICEAL SITE OR BE BANDING GASTRIC VARICES. IF MULTIPLE BANDS ARE PLACED ON THE SAME VARIX, THIS COULD CONTRIBUTE TO BAND DETACHMENT DUE TO ADVANCEMENT TO THE ENDOSCOPE BEYOND THE BANDED SITE.

    Description of Event or Problem · 1

    ESOPHAGEAL VARICES WERE BANDED. APPROX 7 DAYS LATER, WHAT WAS DESCRIBED AS A "MAJOR BLEED AND ULCERATION" OCCURRED. AT THIS TIME, A QUANTITY OF FOUR (4) LIGATORS WITH SIX (6) BAND EACH WERE USED TO CONTROL THE BLEEDING (A TOTAL OF 24 BANDS WERE APPLIED). THE PT REBLED 24 HOURS LATER. THE PHYSICIAN PERFORMED A GASTROSCOPY AND NO BANDS WERE VISIBLE. THE BANDED AREA THAT NO LONGER CONTAINED LIGATOR BANDS WAS DESCRIBED TO CONTAIN A BLEEDING ULCER. THE BANDED AREA WAS ALSO DESCRIBED TO CONTAIN A BLOOD CLOT AFTER 1 DAY. THE PHYSICIAN STATED THE BANDS APPEAR TO HAVE CAUSED THE BLEEDING ULCERS AND NECROSIS. THE BLEEDING WAS CONTROLLED BY GLUING. THE PT WAS REPORTED TO BE "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL, INC. W2958759

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ENDOSCOPE (UNK TYPE)