BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 15056007 · Received July 19, 2022

    Report

    Report Number
    1037905-2022-00400
    Event Type
    Death
    Date Received
    July 19, 2022
    Date of Event
    January 1, 2006
    Report Date
    July 19, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KATSINELOS, 2006. DOI:10.1016/J.GIE.2005.09.051. 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 ARTICLE REPORTED OCCURRENCES OF BLEEDING. BLEEDING IS A KNOWN COMPLICATION OF THESE TYPES OF PROCEDURES. 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 COOK ENDOSCOPY PAPILLOTOMES/NEEDLE KNIVES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. 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 · 0

    THE FOLLOWING WAS PUBLISHED IN A CLINICAL LITERATURE ARTICLE INVOLVING COOK PAPILLOTOMES: "DATA OF 413 PATIENTS WHO UNDERWENT THERAPEUTIC ERCP FROM JANUARY 1994 TO DECEMBER 2004 WERE REVIEWED. AMONG THESE PATIENTS, 63 WERE 90 YEARS OF AGE OR OLDER (GROUP A) AND 350 WERE BETWEEN 70 AND 89 YEARS (GROUP B)... HOSPITAL LOCATION NOT REPORTED- DATA COLLECTED FROM FACILITIES IN THESSALONIKI, GREECE... SPHINCTEROTOMIES AND PRE-CUT PAPILLOTOMIES WERE PERFORMED BY USING... COOK ENDOSCOPY INSTRUMENTS (PAPILLOTOMES, WILSON COOK MEDICAL INC, WINSTON-SALEM, NC). POST SPHINCTEROTOMY BLEEDING AND DEATH WAS REPORTED." IT WAS NOT PUBLISHED IN THE ARTICLE IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. IT WAS PUBLISHED IN THE ARTICLE THAT THE PATIENT EXPERIENCED POST SPHINCTEROTOMY BLEEDING AND DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333986 UNKNOWN KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death OLYMPUS ENDOSCOPE, UNKNOWN MODEL