BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE BIOPSY FORCEPS

    MDR report key: 17499527 · Received August 10, 2023

    Report

    Report Number
    9614641-2023-01140
    Event Type
    Injury
    Date Received
    August 10, 2023
    Date of Event
    May 30, 2023
    Report Date
    August 10, 2023
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FCL
    UDI-DI
    04953170354113
    PMA / PMN Number
    K955065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS SUBMITTED BY THE IMPORTER UNDER THE IMPORTER'S REPORT NUMBER (B)(4). H4: THE SUBJECT DEVICE WAS MANUFACTURED ON NOV 2022 BASED ON THE PROVIDED LOT INFORMATION "2YV". THE SUBJECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. THEREFORE, THE EVENT WAS NOT BE ABLE TO CONFIRMED. ONLY UNUSED/NEW DEVICES STILL IN THEIR ORIGINAL PACKAGING WERE RECEIVED. IT WAS OBSERVED THAT THE DEVICES CAME INSIDE A SEALED, CLEAR, AND STERILE PACKAGE. THERE WERE NO SIGNS OF PHYSICAL DAMAGE OR MISHANDLING ON THE BOX OR TO THE PRODUCT ITSELF. A FUNCTIONAL CHECK WAS PERFORMED; WHEN MANIPULATING THE SLIDER, THE JAWS OPENED AND CLOSED SMOOTHLY AND WITHOUT ANY RESTRICTIONS. JAWS ARE NEW AND INTACT. FOUR ADDITIONAL BOXES WERE SENT IN, ALL WITH THE SAME LOT NUMBER. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE FOUND. THE INSTRUCTION MANUAL CONTAINS THE FOLLOWING DESCRIPTIONS, AND IT WARNS AGAINST THIS EVENT. DO NOT FORCE THE DISTAL END OF THE INSERTION PORTION AGAINST BODY CAVITY TISSUE. DOING SO COULD CAUSE PATIENT INJURY, SUCH AS PERFORATION, BLEEDING, OR MUCOUS MEMBRANE DAMAGE. BIOPSY MAY CAUSE BLEEDING. IF YOU TAKE A LARGE SAMPLE OR PRESS THE INSTRUMENT¿S DISTAL END AGAINST TISSUE EXCESSIVELY, THE RISK OF BLEEDING WILL INCREASE. PERFORM BIOPSY ON MINIMUM NECESSARY SPOTS ONLY. THE FOLLOWING FACTORS MAY HAVE CAUSED THE EVENT: THE APPROACH TO THE TISSUE WAS POOR AND THE TISSUE WAS NOT PRESSED AGAINST THE TISSUE SUFFICIENTLY. THE TISSUE WAS DIFFICULT TO RESECT. THE CUP DID NOT CLOSE COMPLETELY DUE TO EXCESSIVE GRASPING. HOWEVER, WE WERE UNABLE TO IDENTIFY THE ROOT CAUSE OF THE PROBLEM BECAUSE WE WERE UNABLE TO CHECK THE ACTUAL PRODUCT. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION EFFORT BASED ON ENHANCEMENTS MADE TO THE COMPANY¿S MDR AND COMPLAINT HANDLING PROCESSES. CAPAS HAVE BEEN OPENED TO MANAGE THE ACTIONS THAT ARE BEING TAKEN TO REMEDIATE THIS ISSUE AND ENSURE ANY REQUIRED MDR REPORTING IS COMPLETED.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED TO OLYMPUS THAT DURING UNSPECIFIED DIAGNOSTIC PROCEDURES, THE DISPOSABLE BIOPSY FORCEPS WAS TAKING BIG "BITES" OUT OF THE MUCOSA, CAUSING BLEEDING. THE PHYSICIAN WAS UNCOMFORTABLE WITH THE LARGE SAMPLE. SOME OF THE PATIENTS REQUIRED HEMOSTATIC METHODS SUCH AS CAUTERY OR CLIPS. THE PROCEDURES WERE NOT DELAYED DUE TO THE ISSUE AND THE OUTCOME OF THE PROCEDURE WAS UNAFFECTED. THIS EVENT REQUIRES TWO REPORTS. PATIENT IDENTIFIER (B)(6) IS FOR AN INDIVIDUAL PATIENT. PATIENT IDENTIFIER (B)(6) IS FOR "SOME PATIENT'S" OF UNKNOWN QUANTITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063532 DISPOSABLE BIOPSY FORCEPS DISPOSABLE BIOPSY FORCEPS FCL AOMORI OLYMPUS CO., LTD. FB-210U 2Y V 04953170354113

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention