BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME

    MDR report key: 15218333 · Received August 12, 2022

    Report

    Report Number
    1037905-2022-00466
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    May 12, 2021
    Report Date
    August 12, 2022
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # K172665. 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 PRODUCTS SAID TO BE INVOLVED WERE NOT RETURNED FOR EVALUATION. A DEFINITIVE CAUSE FOR THE REPORTED OBSERVATION COULD NOT BE DETERMINED. A DEVICE FAILURE WAS NOT IDENTIFIED IN THE ARTICLE, ONLY POST PROCEDURE COMPLICATIONS. THE INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING POTENTIAL COMPLICATIONS: "POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST." PRIOR TO DISTRIBUTION, ALL DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOMES 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. CITATION: YANG, M.J.; KIM, J.H.; HWANG, J.C.; YOO, B.M.; LI, Y.J.; KIM, S.S.; LIM, S.G. OUTCOMES AND LOOP PATTERN ANALYSIS OF A ROAD-MAP TECHNIQUE FOR ERCP WITH SIDE-VIEWING DUODENOSCOPE IN PATIENTS WITH BILLROTH II GASTRECTOMY (WITH VIDEO). J. PERS. MED. 2021, 11, 404. HTTPS://DOI.ORG/10.3390/JPM11050404.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF THE ATTACHED CLINICAL LITERATURE ARTICLE INVOLVING COOK DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME. ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) IN PATIENTS WHO HAVE UNDERGONE A BILLROTH II GASTRECTOMY IS A MAJOR CHALLENGE. THIS STUDY AIMED TO EVALUATE THE OUTCOMES OF THE ROADMAP TECHNIQUE FOR DUODENAL INTUBATION USING A SIDE-VIEWING DUODENOSCOPE FOR ERCP IN BILLROTH II GASTRECTOMY PATIENTS WITH NAÏVE PAPILLA, AND TO ANALYZE THE FORMATION AND RELEASE PATTERNS OF COMMON BOWEL LOOPS THAT OCCUR WHEN THE DUODENOSCOPE NAVIGATES THE AFFERENT LIMB. OVERALL ADVERSE EVENTS WERE REPORTED AS FOLLOWS: PANCREATITIS: THREE (3) PATIENTS. CHOLECYSTITIS: ONE (1) PATIENT. TRANSIENT RESPIRATORY FAILURE: ONE (1) PATIENT. IT WAS NOT PUBLISHED IN THE ARTICLE IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENTS' BODY OR HOW WERE THE POST-ERCP PANCREATITIS, CHOLECYSTITIS AND TRANSIENT RESPIRATORY FAILURE TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2847863 DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS WILSON-COOK MEDICAL INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention DUODENOSCOPE OLYMPUS, MODEL UNKNOWN