BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 2181574 · Received July 6, 2011

    Report

    Report Number
    1037905-2011-00460
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 3, 2011
    Report Date
    June 6, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    PMA / PMN Number
    K061937
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. CONCLUSION: WE ARE UNABLE TO DETERMINE A DEFINITIVE CAUSE FOR THE REPORT OF BALLOON DAMAGE BECAUSE THE PRODUCT COULD NOT BE EVALUATED. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIRE GUIDED ESOPHAGEAL BALLOON DILATORS ARE SUBJECTED TO A VISUAL EXAMINATION 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: BASED ON THE QUALITY ENGINEERING RISK ASSESSMENT NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED ESOPHAGEAL BALLOON DILATOR. AFTER PREPPING THE BALLOON PER THE IFU, THE BALLOON WAS ADVANCED THROUGH THE ENDOSCOPE AND POSITIONED IN THE ESOPHAGUS. AS INFLATION WAS ATTEMPTED, THE TECH NOTICED THE BALLOON WAS NOT INFLATING AND FLUID BEGAN LEAKING OUT OF THE DISTAL END OF THE BALLOON. THE BALLOON WAS REMOVED FROM THE ENDOSCOPE. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. A FOREIGN OBJECT DID NOT HAVE TO BE RETRIEVED FROM THE PT. NO ADD'L MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KNQ, ESOPHAGEAL DILATOR KNQ WILSON-COOK MEDICAL INC W2881590

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLIANCE INFLATION GUN| DS-60CC (COOK DILATION SYRINGE)| OLYMPUS GIF H180 EGD SCOPE