BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME

    MDR report key: 12193691 · Received July 19, 2021

    Report

    Report Number
    1037905-2021-00331
    Event Type
    Injury
    Date Received
    July 19, 2021
    Date of Event
    July 23, 2019
    Report Date
    July 19, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: AGE: 71.18 +/-10.39 YEARS. GENDER: MALES 58 (77.3); FEMALES 17 (22.7). PMA/510(K) #: K172665. CITATION: CAGLAR, E., ATASOY, D., TOZLU, M., ALTINKAYA, E., DOGAN, S., & SENTURK, H. (2020). EXPERIENCE OF THE ENDOSCOPISTS MATTERS IN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN BILLROTH II GASTRECTOMY PATIENTS. CLINICAL ENDOSCOPY, 53(1), 82¿89. HTTPS://DOI.ORG/10.5946/CE.2019.073. 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. IT IS UNKNOWN AT WHAT TIMES, DURING OR AFTER THE PROCEDURES, THE ADVERSE EFFECTS EXPERIENCED OCCURRED. 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 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.

    Description of Event or Problem · 1

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT VIA A CLINICAL LITERATURE ARTICLE. THE ARTICLE WAS PUBLISHED IN 2019. INCLUDED ARE RELEVANT EXCERPTS FROM THE ARTICLE TO CAPTURE THE THREE (3) CASES OF BLEEDING IN PROCEDURES WHERE THE COOK DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME WAS USED. THE AUTHORS OF THE STUDY ¿AIMED TO INVESTIGATE THE SAFETY AND EFFICACY OF PERFORMING ERCP [ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY] WITH A SIDE-VIEWING ENDOSCOPE IN PATIENTS WHO HAD UNDERGONE A BILLROTH II OPERATION AND TO ASSESS THE ROLE OF ENDOSCOPIST EXPERIENCE. . . DATA OF PATIENTS WHO UNDERWENT BILLROTH II GASTRECTOMY FOR WHOM ERCP WAS PERFORMED BETWEEN 2014 AND 2018 IN TWO ENDOSCOPY CENTERS WERE RETRIEVED. . . THE UPPER GASTROINTESTINAL TRACT WAS FIRST ASSESSED WITH A FRONT-VIEWING ENDOSCOPE. ERCP PROCEDURES WERE PERFORMED UNDER FLUOROSCOPY ... IN CASE OF FAILURE, PRECUT SPHINCTEROTOMY (FUSION; COOK MEDICAL, WINSTON-SALEM, NC, USA), AN ANTEGRADE TECHNIQUE (N=1 PATIENT), AND A DOUBLE GUIDEWIRE TECHNIQUE WERE USED. IN PATIENTS WITH FAILURE IN THE FIRST ATTEMPT WITH THE DUODENOSCOPE, A SECOND ATTEMPT WAS PERFORMED WITH A GASTROSCOPE OR PEDIATRIC COLONOSCOPE 3¿5 DAYS LATER. SPHINCTEROTOMY WAS PERFORMED WITH AN INVERTED SPHINCTEROTOME (BILLROTH II SPHINCTEROTOME; COOK MEDICAL) [SUBJECT OF REPORT] OR INSULATED-TYPE/ORDINARY NEEDLE KNIFE AFTER INSERTING A 5-F STENT IN THE PANCREATIC DUCT, IF NOT POSSIBLE IN THE COMMON BILE DUCT, AND CUTTING FROM THE ROOF TOWARD THE STENT. . .RESULTS. . . NONE OF THE PATIENTS TREATED BY THE INEXPERIENCED ENDOSCOPIST HAD. . .BLEEDING. . .WHEREAS AMONG THOSE TREATED BY THE EXPERIENCED ENDOSCOPIST. . .5% (3/59) HAD BLEEDING. . . BLEEDING WAS DETECTED IN 3 PATIENTS [SUBJECT OF THIS REPORT]. PRECUT SPHINCTEROTOMY WAS PERFORMED IN ALL PATIENTS. . . ALL THE PATIENTS WITH BLEEDING UNDERWENT PRECUT SPHINCTEROTOMY. BLEEDING COMPLICATION RATES WERE REPORTED TO INCREASE AFTER PRECUT IN PATIENTS WHO HAD UNDERGONE BILLROTH II GASTRECTOMY. CONSERVATIVE MANAGEMENT WAS SUCCESSFUL IN ALL THE 3 CASES.¿ IT WAS NOT REPORTED IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE THREE PATIENTS WHO EXPERIENCED BLEEDING WERE SUCCESSFULLY MANAGED CONSERVATIVELY. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS EXPERIENCED BLEEDING FOLLOWING PRECUT SPHINCTEROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088670 DOUBLE LUMEN WIRE GUIDED BILLROTH II SPHINCTEROTOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention