BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OES CHOLEDOCHOFIBERSCOPE

    MDR report key: 22786854 · Received August 12, 2025

    Report

    Report Number
    9610595-2025-17490
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    June 1, 2025
    Report Date
    September 2, 2025
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FBN
    PMA / PMN Number
    K912120
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIER: (B)(6). THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE A CORRECTION, ADDITIONAL INFORMATION FROM THE AUTHOR AND THE RESULTS OF THE COMPLAINT INVESTIGATION. UPDATED FIELDS: B5, H2 AND H6. CORRECTIONS TO B1, B2 AND H1. THIS EVENT WAS INITIALLY CONSERVATIVELY REPORTED AS SERIOUS INJURIES; HOWEVER, UPON FURTHER FOLLOW-UP, THE AUTHOR CONFIRMED THAT THE COMPLICATIONS WERE NOT RELATED TO THE ACTUAL OLYMPUS SCOPE AND NOT RELATED TO DEVICE MALFUNCTION. THUS, CORRECTING B1, B2 AND H1: B1 AND B2 SHOULD NOT BE MARKED AT ALL. H1 SHOULD ALSO NOT BE MARKED. THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR INSPECTION. BASED ON THE RESULTS OF THE INVESTIGATION AND THE AUTHOR'S CONFIRMATION, IT WAS DETERMINED THAT THE OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE COMPLICATIONS REPORTED IN THE LITERATURE. ADDITIONALLY, THERE WAS NO DOCUMENTED DEVICE MALFUNCTION IN THE LITERATURE. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TRANSCYSTIC LAPAROSCOPIC COMMON BILE DUCT EXPLORATION: WHEN TO BAIL." BACKGROUND: TRANSCYSTIC LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) IS A PROCEDURE CONSIDERED IN THE MANAGEMENT OF COMMON BILE DUCT STONES. IN MANY WAYS IT IS SUPERIOR TO ALTERNATIVES SUCH AS ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP); HOWEVER, SURGEONS WHO HAVE LIMITED EXPERIENCE IN CBDE ARE OFTEN RELUCTANT TO PERSIST IN DIFFICULT CASES WITH CONCERNS REGARDING INCREASING COMPLICATION RATES AND WASTE OF THEATER TIME. THIS STUDY AIMS TO PROVIDE AN EVIDENCE-BASED APPROACH TO IDENTIFY POINTS TO AID EARLY ABANDONMENT (¿BAIL¿). METHODS: REVIEW OF ALL LCBDE PERFORMED IN A SINGLE CENTER FROM SEPTEMBER 2008 TO SEPTEMBER 2022 WAS PERFORMED. STATISTICAL ANALYSIS WAS PERFORMED ON SUCCESS AND FAILURE GROUPS, WITH RELEVANT UNDESIRABLE OUTCOMES CHOSEN FOR FURTHER ANALYSIS TO IDENTIFY FACTORS TO BE USED AS A GUIDE TO BAIL. RESULTS: A TOTAL OF 952 PATIENTS WERE IDENTIFIED FOR ANALYSIS. FEMALES REPRESENTED 63.8% (609) OF THE COHORT. SUCCESS WAS REPORTED IN 89.2% (849) OF PROCEDURES. THOSE IN WHOM THE CYSTIC DUCT COULD NOT BE CANNULATED WITH THE CHOLEDOCHOSCOPE, THOSE THAT PROGRESSED TO CHOLEDOCHOTOMY, THOSE WITH A PROLONGED OPERATIVE TIME, AND THOSE WHO HAD ADVERSE OUTCOMES WERE SELECTED AS UNDESIRED OUTCOMES. FACTORS OF AGE, HIGHER ASA, PREOPERATIVE ERCP, AND THOSE WITH PREOPERATIVELY IDENTIFIED STONES OR LARGER STONES AT OPERATION WERE ASSOCIATED WITH HIGHER RATES OF AN UNDESIRED OUTCOME. CONCLUSION: OLDER AND MORE COMORBID PATIENTS, THOSE WHO UNDERWENT PREOPERATIVE ERCP, AND THOSE WITH PREOPERATIVELY OR OPERATIVELY IDENTIFIED LARGE STONES ARE FACTORS THAT SHOULD PROMPT THOSE SURGEONS WHO ARE DEVELOPING THEIR LCBDE EXPERIENCE TO CONSIDER BAILING EARLY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: BILE LEAK (23 PATIENTS). RETURN TO THEATER FOR STONE CAUSE (19 PATIENTS). THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION IDENTIFIED IN THE ARTICLE.

    Description of Event or Problem · 0

    NEW INFORMATION RECEIVED FROM THE AUTHOR STATED THAT ALL OF THE COMPLICATIONS WERE NOT RELATED TO THE ACTUAL OLYMPUS SCOPE AND NOT RELATED TO DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2462164 OES CHOLEDOCHOFIBERSCOPE CHOLEDOCHO FIBERSCOPE FBN AIZU OLYMPUS CO., LTD. CHF-CB30L

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H 1.5F NCIRCLE TIPLESS NITINOL STONE EXTRACTOR BASK| 1.7F NCOMPASS TIPLESS NITINOL STONE EXTRACTOR BASK| 2.2F NCOMPASS TIPLESS NITINOL STONE EXTRACTOR BAS