BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPSY FORCEPS

    MDR report key: 13536568 · Received February 15, 2022

    Report

    Report Number
    8010047-2022-02979
    Event Type
    Injury
    Date Received
    February 15, 2022
    Report Date
    March 15, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FCL
    UDI-DI
    04953170030659
    PMA / PMN Number
    K955065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO OLYMPUS FOR EVALUATION. THE INVESTIGATION IS IN PROCESS. 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 LOT NUMBER WAS NOT PROVIDED. HOWEVER, OLYMPUS ONLY RELEASES PRODUCTS TO MARKET THAT MEET ALL MANUFACTURING SPECIFICATIONS AND FINAL PRODUCT RELEASE CRITERIA. THE CASE IS NOT DUE TO DESIGN. BASED ON THE RESULTS OF THE INVESTIGATION, THE RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT CANNOT BE CONFIRMED. THERE IS NO EVIDENCE OF AN OLYMPUS DEVICE MALFUNCTION. THE ROOT CAUSE CANNOT BE DETERMINED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "TISSUE ACQUISITION FOR DIAGNOSIS OF BILIARY STRICTURES USING PERORAL CHOLANGIOSCOPY OR ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION" BY YUN NAH LEE, JONG HO MOON, ET AL.   THIS PROSPECTIVE SINGLE-CENTER OBSERVATIONAL STUDY AIMED TO EVALUATE THE USEFULNESS OF A DIAGNOSTIC APPROACH USING PERORAL CHOLANGIOSCOPY FORCEPS BIOPSY (POC-FB) OR ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION BIOPSY (EUS-FNAB) ACCORDING TO THE STRICTURE LOCATION IN PATIENTS WITH SUSPECTED MBS. AMONG A TOTAL OF 181 PATIENTS, INITIAL TPB SHOWED MALIGNANCY IN 122 PATIENTS, AND THE DIAGNOSTIC ACCURACY OF INITIAL TPB WAS 71.8% (95% CONFIDENCE INTERVAL [CI] 65.3%¿78.4 %]. OF THE 59 PATIENTS IN WHOM TPB WAS NEGATIVE FOR MALIGNANCY, 32 HAD PROXIMAL BILIARY STRICTURES AND UNDERWENT SUCCESSFUL POC. THE REMAINING 27 PATIENTS HAD DISTAL STRICTURES AND UNDERWENT SUCCESSFUL EUS-FNAB. THE ACCURACY OF MALIGNANCY DETECTION USING POC-FB FOR PROXIMAL BILIARY STRICTURES AND EUS-FNAB FOR DISTAL BILIARY STRICTURES WAS 93.6% (95%CI 84.9%-100%) AND 96.3% (95%CI 89.2%-100 %), RESPECTIVELY. THE OVERALL DIAGNOSTIC ACCURACY FOR THE COMBINATION OF TPB WITH EITHER POC-FB FOR PROXIMAL STRICTURES AND EUS-FNAB FOR DISTAL STRICTURES WAS 98.3% (95 %CI 95.9%-100 %) AND 98.4% (95%CI 95.3%-100 %), RESPECTIVELY. AN APPROACH USING POC-FB OR EUS-FNAB ACCORDING TO THE STRICTURE LOCATION MAY BE USEFUL IN THE DIAGNOSIS OF SUSPECTED MBS.   THE AUTHORS USED 3 OLYMPUS DEVICES AND DID NOT SPECIFY WHICH DEVICE MAY HAVE BEEN INVOLVED WITH THE REPORTED CHOLANGITIS (2 PATIENTS FROM POC GROUP). THIS ARTICLE INCLUDES 3 REPORTS: (B)(6), MODEL: FB39Q - LOT: UNKNOWN- AE: CHOLANGITIS. (B)(6), MODEL: GIF-XP260NS- SN: UNKNOWN- AE: CHOLANGITIS. (B)(6), MODEL: GIF-XP260N- SN: UNKNOWN- AE: CHOLANGITIS. THIS REPORT IS 1 OF 3 FOR (B)(6), MODEL: FB39Q - LOT: UNKNOWN- AE: CHOLANGITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1733830 BIOPSY FORCEPS BIOPSY FORCEPS FCL OLYMPUS MEDICAL SYSTEMS CORP. FB-39Q-1 UNKNOWN(LITERATURE) 04953170030659

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other GIF-XP260NS OR GIF-XP260N