BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE ELECTROSURGICAL SNARE

    MDR report key: 18246462 · Received December 1, 2023

    Report

    Report Number
    9614641-2023-01818
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Report Date
    January 2, 2024
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    FDI
    UDI-DI
    04953170037009
    PMA / PMN Number
    K902735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6 TYPE OF INVESTIGATION: THE DEVICE WAS DISCARDED AND CODE "10 - TESTING OF ACTUAL/SUSPECTED DEVICE" WAS INADVERTENTLY ADDED. THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. THE DEVICE WAS MANUFACTURED IN MARCH 2023, BUT THE SPECIFIC DATE IS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE RESULTS OF THE INVESTIGATION, THE EVENT OCCURRED BECAUSE THE USER MISTAKENLY RECOGNIZED THE SUBJECT DEVICE HAD A FUNCTION AS A COLD SNARE. THE EVENT CAN BE PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: ·"THE DISPOSABLE ELECTROSURGICAL SNARE SD-210/221/230/240 SERIES HAVE BEEN DESIGNED TO BE USED WITH AN OLYMPUS ENDOSCOPE TO ELECTROSURGICALLY RESECT TISSUE WITHIN THE DIGESTIVE TRACT. ·MAKE SURE THAT ELECTRICITY IS SUPPLIED TO THE INSTRUMENT WHEN MAKING AN INCISION. INCISION WITHOUT ELECTRICITY MAY RESULT IN HEMORRHAGES OR MUCOUS MEMBRANE DAMAGE." OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED TO OLYMPUS FOR EVALUATION. OLYMPUS NOTICED THAT THE DEVICE IS ONLY A HOT SNARE, AND IN THE HOSPITAL SYSTEM IT WAS MENTIONED THAT IT IS A COLD/HOT SNARE. OLYMPUS HAS CONTACTED HOSPITAL TO ADVISE ABOUT THE USE OF THIS DEVICE AND IT HAS BEEN REQUESTED THAT THE HOSPITAL CHANGES THEIR SYSTEM SO THAT THE DESCRIPTION OF THE PRODUCT IS MARKED AS ONLY A HOT OPTION. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR IF ANY ADDITIONAL INFORMATION IS PROVIDED BY THE USER FACILITY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO OLYMPUS THAT THE DISPOSABLE ELECTROSURGICAL SNARE COLD SNARE OPTION DOES NOT WORK AND THEY HAD TO CHANGE TO HOT SNARE DURING PROCEDURE AND THEY NOTICED THE PACKAGE DOES NOT MENTION COLD SNARE AT ALL. THE PROCEDURE WAS FINISHED WITH THE HOT OPTION. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1399198 DISPOSABLE ELECTROSURGICAL SNARE DISPOSABLE ELECTROSURGICAL SNARE FDI AOMORI OLYMPUS CO., LTD. SD-210U-25 33V 04953170037009

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown