BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUIBREGTSE NEEDLE KNIFE PAPILLOTOME

    MDR report key: 15159482 · Received August 3, 2022

    Report

    Report Number
    1037905-2022-00446
    Event Type
    Death
    Date Received
    August 3, 2022
    Date of Event
    January 1, 2008
    Report Date
    August 29, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    PMA / PMN Number
    K972674
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED WITHIN 30 DAYS OF SUBMISSION OF THIS REPORT.

    Additional Manufacturer Narrative · 0

    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. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. 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. HOWEVER, A DEVICE FAILURE WAS NOT REPORTED IN THE ARTICLE. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING POTENTIAL COMPLICATIONS: "POTENTIAL ADVERSE EVENTS ASSOCIATED WITH PAPILLOTOMY INCLUDE BUT ARE NOT LIMITED TO: PANCREATITIS, BLEEDING, PERFORATION, AND INFECTION." PRIOR TO DISTRIBUTION, ALL HUIBREGTSE NEEDLE KNIFE PAPILLOTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. 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.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF AN EVENT INVOLVING A COOK HUIBREGTSE NEEDLE KNIFE PAPILLOTOME FROM A POST MARKET CLINICAL FOLLOW UP STUDY REPORT. IT WAS REPORTED THAT ONE (1) PATIENT EXPERIENCED A PERFORATION OF THE GI TRACT DURING THE PROCEDURE AND THE STUDY CI [CONFIDENCE INTERVAL] DEEMED THIS DEATH AS POSSIBLY, BUT NOT DEFINITELY, RELATED TO THE DEVICE. THIS PATIENT ALSO HAD METASTATIC CANCER IN THE LIVER, LUNGS, BRAIN, AND LEFT KIDNEY. IT WAS NOT REPORTED IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. PATIENT EXPERIENCED A PERFORATION OF THE GI TRACT AND DEATH. THE STUDY CI [CONFIDENCE INTERVAL] DEEMED THIS DEATH AS POSSIBLY, BUT NOT DEFINITELY RELATED TO THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED IN THE STUDY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703797 HUIBREGTSE NEEDLE KNIFE PAPILLOTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| D ENDOSCOPE, UNKNOWN MAKE AND MODEL