BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE BALLOON ESOPHAGEAL

    MDR report key: 2803165 · Received October 19, 2012

    Report

    Report Number
    1037905-2012-00586
    Event Type
    Malfunction
    Date Received
    October 19, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 28, 2012
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION: A PRODUCT EVALUATION WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVALUATION. 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 EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT DETERMINED. A REPORTER WAS UNABLE TO SPECIFY IF THE BALLOON WAS LUBRICATE PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTIONS FOR USE DIRECT THE USER TO APPLY A LUBRICATING AGENT TO THE BALLOON TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE ACCESSORY CHANNEL. THIS ACTIVITY WILL AID IN ENDOSCOPE ADVANCEMENT AND BALLOON PRESERVATION. THE REPORTER WAS UNABLE TO SPECIFY IF NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON DEVICE PRIOR TO ADVANCEMENT THROUGH THE ACCESSORY CHANNEL OF THE ENDOSCOPE. THE INSTRUCTION FOR USE DIRECT THE USER TO APPLY NEGATIVE PRESSURE TO THE CATHETER TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE. THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE ESOPHAGEAL BALLOON DILATORS ARE SUBJECTED TO A LEAK TEST 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 ACTIONS: 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

    DURING AN ESOPHAGEAL DILATION, A COOK HERCULES 3 STAGE BALLOON WAS INFLATED WITH STERILE WATER. THE BALLOON HELD AT 18 (MM) AND 19 [MM], HOWEVER WHEN INCREASED TO 20 [MM] THE BALLOON BURST. ANOTHER ONE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PT'S BODY. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERCULES 3 STAGE BALLOON ESOPHAGEAL KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC W3184291

    Patients

    Seq Age Sex Outcome Treatment
    1 REQUEST OLYMPUS ENDOSCOPE (UNKNOWN MODEL NUMBER)