BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC

    MDR report key: 11968342 · Received June 9, 2021

    Report

    Report Number
    1037905-2021-00239
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Date of Event
    May 19, 2021
    Report Date
    August 4, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KCF
    UDI-DI
    10827002517964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED: SECTION D2 & 2B ¿ SUSPECT MEDICAL DEVICE COMMON NAME - DILATOR, ESOPHAGEAL AND PRODUCT CODE - KCF INVESTIGATION EVALUATION: OUR LABORATORY EVALUATION OF THE PRODUCT SAID TO BE INVOLVED CONFIRMED THE REPORT. A FUNCTIONAL TEST WAS PERFORMED ON THE RETURNED DEVICE. A COOK DILATION SYRINGE (DS-60CC-S) WAS FILLED WITH WATER AND ATTACHED TO THE BALLOON INFLATION PORT. THE SYRINGE WAS PLACED INTO AN INFLATION HANDLE, AND NEGATIVE PRESSURE WAS APPLIED TO THE BALLOON. AFTER APPLYING NEGATIVE PRESSURE, THE BALLOON WAS ATTEMPTED TO BE INFLATED. THE BALLOON WOULD NOT HOLD PRESSURE AND LEAKAGE WAS OBSERVED FROM A PINHOLE ON THE PROXIMAL END OF THE BALLOON MATERIAL. A PRODUCT-SPECIFIC DISCREPANCY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS OBSERVATION WAS NOT OBSERVED DURING OUR LABORATORY ANALYSIS. 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 CONCLUSION: A DEFINITIVE CAUSE FOR THIS OBSERVATION COULD NOT BE DETERMINED BECAUSE THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. DUE TO A VARIETY OF CLINICAL CONDITIONS SUCH AS PATIENT ANATOMY, ENDOSCOPE POSITION OR PROGRESSION OF DISEASE STATE, WE COULD NOT REPRODUCE THE ACTUAL CONDITIONS OF PRODUCT USAGE DURING OUR LABORATORY ANALYSIS. THIS LIMITS OUR ABILITY TO CONCLUSIVELY DETERMINE A CAUSE. IT IS UNKNOWN IF LUBRICATION AND NEGATIVE PRESSURE WERE APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. A CONTRIBUTING FACTOR TO BALLOON MATERIAL DAMAGE IS FAILURE TO LUBRICATE THE BALLOON WITH A LUBRICATING AGENT. THE INSTRUCTIONS FOR USE DIRECT THE USER: "APPLY A LUBRICATING AGENT TO THE BALLOON TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE ACCESSORY CHANNEL." THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. ANOTHER CONTRIBUTING FACTOR TO A LEAK IN THE BALLOON MATERIAL IS FAILURE TO APPLY NEGATIVE PRESSURE TO THE BALLOON DILATOR PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. THE INSTRUCTIONS FOR USE DIRECT THE USER "TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE, APPLY NEGATIVE PRESSURE TO THE DEVICE." IN ADDITION, THE USER IS FURTHER INSTRUCTED TO "MAINTAIN BALLOON DEFLATION WITH NEGATIVE PRESSURE AND INTRODUCE INTO ENDOSCOPE ACCESSORY CHANNEL, ADVANCING IN SHORT INCREMENTS UNTIL BALLOON IS COMPLETELY VISUALIZED ENDOSCOPICALLY." THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. A LEAKAGE CAN ALSO OCCUR IF THE BALLOON COMES INTO CONTACT WITH A SHARP OBJECT OR A BURR IN THE ENDOSCOPE CHANNEL. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: 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.

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE COMMON NAME - DILATOR, ESOPHAGEAL AND PRODUCT CODE - KCF. 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 CONCLUSION: 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 BE DETERMINED. IT IS UNKNOWN IF LUBRICATION AND NEGATIVE PRESSURE WERE APPLIED TO THE BALLOON PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. A CONTRIBUTING FACTOR TO BALLOON MATERIAL DAMAGE IS FAILURE TO LUBRICATE THE BALLOON WITH A LUBRICATING AGENT. THE INSTRUCTIONS FOR USE DIRECT THE USER: "APPLY A LUBRICATING AGENT TO THE BALLOON TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE ACCESSORY CHANNEL." THIS ACTIVITY WILL AID IN ENDOSCOPIC ADVANCEMENT AND BALLOON PRESERVATION. ANOTHER CONTRIBUTING FACTOR TO A LEAK IN THE BALLOON MATERIAL IS FAILURE TO APPLY NEGATIVE PRESSURE TO THE BALLOON DILATOR PRIOR TO ADVANCEMENT THROUGH THE ENDOSCOPE. NEGATIVE PRESSURE WILL ALSO AID IN BALLOON PRESERVATION AND OPTIMIZE BALLOON PERFORMANCE. THE INSTRUCTIONS FOR USE DIRECT THE USER "TO FACILITATE PASSAGE THROUGH THE ENDOSCOPE, APPLY NEGATIVE PRESSURE TO THE DEVICE." IN ADDITION, THE USER IS FURTHER INSTRUCTED TO "MAINTAIN BALLOON DEFLATION WITH NEGATIVE PRESSURE AND INTRODUCE INTO ENDOSCOPE ACCESSORY CHANNEL, ADVANCING IN SHORT INCREMENTS UNTIL BALLOON IS COMPLETELY VISUALIZED ENDOSCOPICALLY." THE APPLICATION OF NEGATIVE PRESSURE WILL ASPIRATE ALL RESIDUAL AIR FROM THE BALLOON AND EASE ENDOSCOPIC ADVANCEMENT. A LEAKAGE CAN ALSO OCCUR IF THE BALLOON COMES INTO CONTACT WITH A SHARP OBJECT OR A BURR IN THE ENDOSCOPE CHANNEL. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TESTING TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MANUFACTURING 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

    DURING A DILATION OF THE GASTROINTESTINAL TRACT, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC DEVICE. IT WAS REPORTED THAT THERE WAS ESOPHAGUS STENOSIS IN THE GASTROINTESTINAL TRACT, AND THE REPORTED DEVICE WAS INSERTED TRANSENDOSCOPICALLY. WHEN THE PRESSURE WAS APPLIED TO THE REPORTED BALLOON USING AN INFLATOR AT THE STRICTURE, IT WAS CONFIRMED THAT THE PRESSURE DID NOT INCREASE. WHEN THE REPORTED DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND PRESSURIZED OUTSIDE THE PATIENT'S BODY, A PINHOLE WAS OBSERVED. THE USE OF THE REPORTED DEVICE WAS DISCONTINUED AND THE PROCEDURE WAS COMPLETED USING ANOTHER MANUFACTURER'S DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868358 HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC KCF COOK ENDOSCOPY W4428281 10827002517964

    Patients

    Seq Age Sex Outcome Treatment
    1 ENDOSCOPE - OLYMPUS GIF-H290T