BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OES CHOLEDOCHO FIBERSCOPE

    MDR report key: 17758857 · Received September 15, 2023

    Report

    Report Number
    9610595-2023-13435
    Event Type
    Injury
    Date Received
    September 15, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 6, 2023
    Manufacturer
    AIZU OLYMPUS CO., LTD.
    Product Code
    FBO
    PMA / PMN Number
    K843084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE AUTHOR.

    Additional Manufacturer Narrative · 0

    SINCE THE LITERATURE DESCRIBED "5 MM CHOLEDOCHOSCOPE", OLYMPUS SELECTED "CHF-P60" AS A REPRESENTATIVE PRODUCT. THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. THE LITERATURE ARTICLE IS ATTACHED FOR ADDITIONAL INFORMATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH DEVICE EVALUATION RESULTS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE HISTORY RECORD WAS UNABLE TO BE REVIEWED FOR THIS DEVICE SINCE THE SERIAL AND/OR LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENTS CANNOT BE CONFIRMED. THERE WAS NO COMPLAINT REPORTED ON THE SUBJECT DEVICE. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. IN ADDITION, THE MALFUNCTION OF THE DEVICE HAS NOT BEEN REPORTED, AND FROM CLINICAL/MEDICAL EVALUATION AND RISK ASSESSMENT, IT IS POSSIBLE THAT THE REPORTED EVENT IS AN ACCIDENT, OR A COMPLICATION ASSOCIATED WITH A PROCEDURE USING THE SUBJECT DEVICE. THEREFORE, THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR: IN THE MEDICAL OPINION OF THE AUTHOR, THE OLYMPUS DEVICE DID NOT CAUSE MALFUNCTION NOR THE ADVERSE EVENTS REPORTED.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "LAPAROSCOPIC COMMON BILE DUCT EXPLORATION WITH PRIMARY CLOSURE COULD BE SAFELY PERFORMED AMONG ELDERLY PATIENTS WITH CHOLEDOCHOLITHIASIS". BACKGROUND: FOR PATIENTS WITH CHOLEDOCHOLITHIASIS, LAPAROSCOPIC COMMON BILE DUCT EXPLORATION (LCBDE) IS PREFERRED OVER OPEN SURGERY. WHETHER PRIMARY CLOSURE OF THE COMMON BILE DUCT (CBD) SHOULD BE PERFORMED UPON COMPLETION OF CHOLEDOCHOTOMY REMAINS UNCLEAR, AND THE CORRESPONDING INDICATIONS FOR PRIMARY CLOSURE OF THE COMMON BILE DUCT HAVE YET TO BE FULLY IDENTIFIED. THIS STUDY WAS PERFORMED TO EVALUATE THE SAFETY AND FEASIBILITY OF PRIMARY CLOSURE OF CBD AMONG ELDERLY PATIENTS (= 70 YEARS) AFTER LCBDE. METHODS: PATIENTS WITH CHOLEDOCHOLITHIASIS WHO HAD UNDERGONE LCBDE WITH PRIMARY CLOSURE OF THE CBD BETWEEN JULY 2014 AND DECEMBER 2020 WERE RETROSPECTIVELY REVIEWED. INCLUDED PATIENTS WERE ASSIGNED INTO TWO GROUPS (GROUP A: =70 YEARS AND GROUP B: <70 YEARS) ACCORDING TO AGE. GROUP A WAS COMPARED WITH GROUP B IN TERMS OF PREOPERATIVE CHARACTERISTICS, INTRAOPERATIVE RESULTS AND POSTOPERATIVE OUTCOMES. RESULTS: THE MEAN OPERATIVE TIME FOR GROUP A WAS 176.59 MIN (± 68.950), WHILE THE MEAN OPERATIVE TIME FOR GROUP B WAS 167.64 MIN (± 69.635) (P = 0.324). THE MEAN HOSPITAL STAY AFTER SURGERY FOR GROUP A WAS 8.43 DAYS (± 4.440), WHILE THAT FOR GROUP B WAS 8.30 DAYS (± 5.203) (P = 0.849). THREE PATIENTS IN GROUP A EXPERIENCED BILE LEAKAGE, WHILE BILE LEAKAGE OCCURRED IN 10 PATIENTS IN GROUP B (3.8% VS. 4.5%, P = 0.781). GROUP A WAS NOT SIGNIFICANTLY DIFFERENT FROM GROUP B IN TERMS OF POSTOPERATIVE COMPLICATIONS AND 30-DAY MORTALITY EXCEPT PNEUMONIA (P = 0.016), ACUTE CARDIOVASCULAR EVENT (P = 0.005) AND ICU OBSERVATION (P = 0.037). AFTER A MEDIAN FOLLOW-UP TIME OF 60 MONTHS, 2 PATIENTS IN GROUP A AND 2 PATIENTS IN GROUP B EXPERIENCED STONE RECURRENCE (2.5% VS. 0.9%, P = 0.612). ONE PATIENT IN GROUP A EXPERIENCED STENOSIS OF THE CBD, WHILE STENOSIS OF THE CBD OCCURRED IN 5 PATIENTS IN GROUP B (1.3% VS. 2.2%, P = 0.937). CONCLUSIONS: PRIMARY CLOSURE OF CBD UPON COMPLETION OF LCBDE COULD BE SAFELY PERFORMED AMONG PATIENTS = 70 YEARS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: BLOOD TRANSFUSION - 4 PATIENTS. ICU OBSERVATION - 10 PATIENTS. REMNANT STONE - 13 PATIENTS. RECURRENT STONE - 4 PATIENTS. BILE LEAKAGE - 13 PATIENTS. CBD STRICTURE - 6 PATIENTS. PNEUMONIA - 9 PATIENTS. ACUTE CARDIOVASCULAR EVENT - 4 PATIENTS. INTRA-ABDOMINAL HEMORRHAGE - 4 PATIENTS. FEVER - 20 PATIENTS. URINARY RETENTION - 1 PATIENT. 30-DAY MORTALITY - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 2 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): CHF-P60 OES CHOLEDOCHO FIBERSCOPE FOR PATIENT DEATH. (B)(6): CHF-P60 OES CHOLEDOCHO FIBERSCOPE FOR OTHER ADVERSE EVENTS. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039968 OES CHOLEDOCHO FIBERSCOPE CHOLEDOCHO FIBERSCOPE FBO AIZU OLYMPUS CO., LTD. CHF-P60

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R