BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6 SHOOTER SAEED MULTI-BAND LIGATOR

    MDR report key: 3140356 · Received May 23, 2013

    Report

    Report Number
    1037905-2013-00281
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 25, 2013
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    MND
    PMA / PMN Number
    K944220
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. INVESTIGATION CONCLUSIONS: 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. THE INSTRUCTIONS FOR USE INSTRUCTS THE USER TO ENSURE THE BARREL IS ADVANCED AS FAR AS POSSIBLE ONTO THE TIP OF THE ENDOSCOPE AND CAUTIONS THE USER NOT TO PLACE LUBRICANT INSIDE THE BARREL. THE CAUTION LABEL ON THE DEVICE LISTS THE RECOMMENDED ENDOSCOPE SIZE FOR EACH REORDER NUMBER. THE CAUTION LABEL ON THE DEVICE INSTRUCTS THE USER TO "ENSURE BARREL IS FULLY ADVANCED INTO TIP OF ENDOSCOPE. FAILURE TO DO SO MAY RESULT IN BARREL BECOMING DISLODGED." THE INSTRUCTIONS FOR USE DIRECT THE USER TO LUBRICATE THE ENDOSCOPE AND EXTERIOR PORTION OF THE BARREL. THE BARREL CAN DISLODGE IF LUBRICANT IS APPLIED TO THE ENDOSCOPE PRIOR TO ATTACHING THE BARREL OR IF LUBRICANT IS ALLOWED INSIDE THE BARREL BEFORE THE LOADING PROCESS. THE INSTRUCTIONS FOR USER CAUTION THE USER NOT TO PLACE LUBRICANT INSIDE THE BARREL. 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 REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED RARE. CORRECTIVE ACTION IS NOT WARRANTED AT THIS TIME BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT. QUALITY ASSURANCE WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS AND REASSESS THE RISK ASSESSMENT RESULTS AS POST MARKET FEEDBACK CONTINUES TO BECOME AVAILABLE.

    Description of Event or Problem · 1

    AT THE END OF AN ESOPHAGOGASTRODUODENOCSOPY (EGD) WITH BANDING, UPON REMOVAL OF THE ENDOSCOPE, THE PLASTIC BANDING DEVICE [LIGATOR BARREL] BECAME DISLODGED AS PT WAS HAVING BRONCHIAL SPASMS. ANESTHESIA REMOVED THE DEVICE WITH LONG FORCEPS [BARREL WAS LOCATED] NEXT TO VOCAL CORDS, PT INTUBATED BY ANESTHESIA AND TRANSFER TO PACU (POST ANESTHESIA CARE UNIT). THE PT WAS KEPT FOR OBSERVATION OVERNIGHT AND RELEASED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229084 6 SHOOTER SAEED MULTI-BAND LIGATOR MND, LIGATOR, ESOPHAGEAL MND WILSON-COOK MEDICAL INC W3232539

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention OLYMPUS ENDOSCOPE GIFH180, SERIAL# (B)(4)