BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME

    MDR report key: 18889046 · Received March 12, 2024

    Report

    Report Number
    1037905-2024-00150
    Event Type
    Injury
    Date Received
    March 12, 2024
    Date of Event
    April 6, 2023
    Report Date
    March 12, 2024
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. BUM KIM, HYUN KIM, ET AL. - COMPARISON OF ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY OUTCOMES BETWEEN CAP-FITTED FORWARD AND SIDE VIEWING ENDOSCOPES IN PATIENTS WITH BILLROTH II ANASTOMOSIS ¿ PUBLISHED ON 06 APR 2023 - HTTPS://DOI.ORG/10.1186/S12876-023-02701-X.

    Description of Event or Problem · 0

    COOK BECAME AWARE OF A CLINICAL LITERATURE ARTICLE INVOLVING COOK DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME. PLEASE SEE BELOW FOR RELEVANT EXCERPTS OF THIS ARTICLE: "THE MEDICAL RECORDS OF PATIENTS WITH A PREVIOUS HISTORY OF SUBTOTAL GASTRECTOMY USING BILLROTH II RECONSTRUCTION WHO UNDERWENT ERCP AT YEUNGNAM UNIVERSITY HOSPITAL BETWEEN JANUARY 2004 AND DECEMBER 2020 WERE REVIEWED RETROSPECTIVELY... SELECTIVE CANNULATION OF THE BILE DUCT WAS INITIALLY TRIED WITH A CATHETER (GLO-TIP CATHETER; COOK MEDICAL, BLOOMINGTON, IN, USA, OR INVERTED SPHINCTEROTOME (BILLROTH II SPHINCTEROTOME; COOK MEDICAL, BLOOMINGTON, IN, USA) ON ENDOSCOPISTS DECISION... POST-ERCP PANCREATITIS WAS DEFINED AS A MEDICAL CONDITION INVOLVING ABDOMINAL PAIN AND ELEVATED PANCREATIC ENZYMES (AMYLASE OR LIPASE) > THREE TIMES THE UPPER NORMAL LIMIT... PERFORATION WAS CONSIDERED IF FREE AIR WAS PRESENT IN THE RETROPERITONEUM OR INTRAPERITONEALLY ON THE RADIOGRAPH OBTAINED AFTER ERCP... THE SUCCESS RATE OF SELECTIVE BILE DUCT CANNULATION AT THE INITIAL SESSION TENDED TO BE HIGHER IN THE SE [SIDE VIEWING ENDOSCOPES] GROUP THAN IN THE CE [CAP-FITTED FORWARD ENDOSCOPES] GROUP WITHOUT STATISTICAL SIGNIFICANCE (94.5% VS. 87.6%, P = 0.186); THE FINAL SUCCESS RATE OF SELECTIVE BILE DUCT CANNULATION WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN THE SE AND CE GROUPS (98.2% VS. 95.6%, P = 0.665)... THE RATE OF TOTAL ERCP-RELATED ADVERSE EVENTS WAS HIGHER IN THE CE GROUP THAN IN THE SE GROUP, BUT THE DIFFERENCE WAS NOT STATISTICALLY SIGNIFICANT (15.9% VS. 7.3%, P = 0.147). AMONG THE ADVERSE EVENTS, THE RATE OF POST-ERCP PANCREATITIS WAS HIGHER IN THE CE GROUP THAN IN THE SE GROUP (12.4% VS. 5.5%, P = 0.186). THE SEVERITY OF PANCREATITIS WAS MILD IN MOST CASES, AND ALL PATIENTS RECOVERED WITH CONSERVATIVE TREATMENT. THE RATE OF HYPERAMYLASEMIA DID NOT DIFFER BETWEEN THE TWO GROUPS. PERFORATION DEVELOPED IN ONE CASE IN EACH GROUP. DUODENAL PERFORATION DEVELOPED AT PROXIMAL SITE OF MAJOR DUODENAL PAPILLA IN SE GROUP AND WAS MANAGED WITH ENDOSCOPIC CLIPPING. [AFFERENT LIMB PERFORATION DEVELOPED IN CE GROUP AND THE PATIENT DIED AFTER SURGICAL PRIMARY CLOSURE]. INFECTIONS, INCLUDING CHOLANGITIS AND CHOLECYSTITIS, DEVELOPED IN ONLY TWO CASES IN THE CE GROUP. THE SEVERITY OF EACH CASE OF CHOLANGITIS AND CHOLECYSTITIS WAS GRADE I ACCORDING TO TOKYO GUIDELINE 2018... " THE MALFUNCTIONS AND ADVERSE EVENTS ARE ORGANIZED AS FOLLOWS: PTG-20-6-BII-NG - CLINICAL RELATED COMPLICATIONS: [SUBJECT OF THIS REPORT] 9 - PANCREATITIS. 1 - DUODENAL PERFORATION AT PROXIMAL SITE OF MAJOR DUODENAL PAPILLA. PANCREATITIS - CONSERVATIVE TREATMENT. PERFORATION - ENDOSCOPIC CLIPPING. A SEPARATE EMDR WILL BE SENT TO CAPTURE THESE CLINICAL COMPLICATIONS WITH THE GLO-TIP ERCP CATHETER, SINCE IT WAS NOT PUBLISHED WHICH COOK DEVICE CAUSED OR CONTRIBUTED. IT WAS NOT REPORTED IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. PANCREATITIS WAS TREATED CONSERVATIVELY AND PERFORATION WAS TREATED WITH ENDOSCOPIC CLIPPING. NO FURTHER INFORMATION WAS PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717144 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 NA Unknown Required Intervention ENDOSCOPE, UNKNOWN MAKE OR MODEL