BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSION OMNI-TOME

    MDR report key: 12189300 · Received July 19, 2021

    Report

    Report Number
    1037905-2021-00320
    Event Type
    Injury
    Date Received
    July 19, 2021
    Report Date
    August 4, 2021
    Manufacturer
    COOK ENDOSCOPY
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A. PATIENT INFORMATION AGE: AVERAGE AGE FOR TPS WAS 60.2 YEARS OLD. GENDER: 53.7% FEMALE PMA/520(K #): K172288. CITATION: REJESKI, J., HINES, M., JONES, J., CONWAY, J., MISHRA, G., EVANS, J., & PAWA, R. (2020). OUTCOMES OF PRECUT SPHINCTEROTOMY TECHNIQUES IN CASES OF DIFFICULT BILIARY ACCESS. FRONTLINE GASTROENTEROLOGY, 12(2), 113¿117. HTTPS://DOI.ORG/10.1136/FLGASTRO-2019-101380. 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 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 FUSION OMNI-TOME SPHINCTEROTOMES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL TEST TO ENSURE DEVICE INTEGRITY. CORRECTIVE ACTION: A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED AND THIS REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF OCCURRENCE IS CONSIDERED REMOTE. 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.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION: AGE: AVERAGE AGE FOR TPS WAS 60.2 YEARS OLD. GENDER: 53.7% FEMALE. PMA/520(K #): K172288. CITATION: REJESKI, J., HINES, M., JONES, J., CONWAY, J., MISHRA, G., EVANS, J., & PAWA, R. (2020). OUTCOMES OF PRECUT SPHINCTEROTOMY TECHNIQUES IN CASES OF DIFFICULT BILIARY ACCESS. FRONTLINE GASTROENTEROLOGY, 12(2), 113¿117. HTTPS://DOI.ORG/10.1136/FLGASTRO-2019-101380. THE INVESTIGATION IS ON-GOING. A FOLLOW-UP EMDR WILL BE PROVIDED FOLLOWING THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    COOK ENDOSCOPY WAS NOTIFIED OF THIS EVENT VIA A CLINICAL LITERATURE ARTICLE. THE ARTICLE WAS PUBLISHED IN 2020 AND IT WAS REPORTED THAT TWO (2) PATIENTS EXPERIENCED BLEEDING IN PROCEDURES WHERE COOK FUSION OMNI-TOME SPHINCTEROTOMES WERE USED. INCLUDED ARE RELEVANT EXCERPTS FROM THE ARTICLE: THIS STUDY ¿AIMS TO DEFINE SUCCESS AND COMPLICATION RATES OF ... TPS [TRANSPANCREATIC PAPILLARY SEPTOTOMY] TECHNIQUES FOR DIFFICULT BILIARY ACCESS CASES AS EXPERIENCED AT A SINGLE, HIGH-VOLUME ENDOSCOPY CENTRE. . . WE PERFORMED OUR STUDY AT A LARGE, TERTIARY-CARE MEDICAL CENTRE WHERE ALL ERCPS [ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY] WERE PERFORMED BY, OR UNDER THE DIRECT SUPERVISION OF, TWO EXPERIENCED ADVANCED ENDOSCOPIST. . . WE RETROSPECTIVELY INTERROGATED OUR ENDOSCOPY REPORT DATABASE TO IDENTIFY ALL ERCPS PERFORMED AT OUR MEDICAL CENTRE BETWEEN 1 JUNE 2014 AND 30 JUNE 2017. . . WE IDENTIFIED ALL PATIENTS WHO UNDERWENT ERCP DURING THIS TIME AND SUBSEQUENTLY PERFORMED A CHART REVIEW TO IDENTIFY PROCEDURAL DETAILS AND REVIEW AT LEAST 4 MONTHS OF POST-PROCEDURE FOLLOW-UP DATA. . ALL TPS WERE PERFORMED WITH EITHER A FUSION OMNI-TOME [SUBJECT OF REPORT] OR A HOWELL D.A.S.H. SPHINCTEROTOME...TPS WAS PERFORMED IF THE PANCREATIC DUCT WAS PREFERENTIALLY CANNULATED MORE THAN TWICE, AT WHICH POINT, ERBE ELECTROCAUTERY WAS APPLIED WITH USE OF THE BOW KNIFE FUNCTION IN THE DIRECTION OF THE BILE DUCT IN AN EFFORT TO INCISE THE SEPTUM AND AFFORD FOR SUBSEQUENT CANNULATION OF THE BILE DUCT... BLEEDING OCCURRED IN 2 (2.3%) PATIENTS IN THE TPS GROUP [SUBJECT OF REPORT]. IT WAS NOT REPORTED IF A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. IT WAS NOT REPORTED IF THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, HOWEVER INTERVENTION MAY HAVE BEEN COMPLETED. ACCORDING TO THE INITIAL REPORTER, THE PATIENTS EXPERIENCED BLEEDING FOLLOWING ERCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087681 FUSION OMNI-TOME KNS, UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) KNS COOK ENDOSCOPY UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ERBE VIO 300D| PENTAX, ED-3490TKOR ED-3270K