BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODENOVIDEOSCOPE

    MDR report key: 13283140 · Received January 18, 2022

    Report

    Report Number
    8010047-2022-01575
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Report Date
    December 8, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    FDT
    UDI-DI
    04953170229459
    PMA / PMN Number
    K954451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE INSPECTION FOUND WEAR OF ANGLE WIRE, BENDING ANGLE IN UP/DOWN/LEFT/RIGHT DIRECTION AND DOES NOT MEET THE STANDARD VALUE. THE CUSTOMER REPORTED ISSUE COULD BE CONFIRMED. FURTHERMORE, FOREIGN MATERIAL WAS FOUND ON THE FORCEPS ELEVATOR. INSUFFICIENT CLEANING WAS NOTED BY SERVICE REPAIR. IN ADDITION, THE FOLLOWING FINDINGS WERE NOTED BELOW : ADHESIVE AROUND OBJECTIVE LENS HAS A CRACK. OBJECTIVE LENS HAS A SCRATCH. ADHESIVE ON A-RUBBER HAS WEAR. CONNECTING TUBE HAS A SCRATCH. FORCEPS CHANNEL PORT HAS A DENT. SW1 (SWITCH) HAS A SCRATCH. S-CYLINDER IS DIRTY. S-COVER HAS A SCRATCH. DUE TO DEFORMATION OF BENDING TUBE, THE PLAY OF U/D/R/L KNOB IS OUT OF THE STANDARD VALUE LG-BUNDLE HAS BREAKAGE. C-COVER HAS A DENT. ADHESIVE AROUND LG LENS HAS A CRACK. INVESTIGATION IS ONGOING. THIS REPORT WILL BE SUPPLEMENTED ACCORDINGLY FOLLOWING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTION TO G3 OF THE INITIAL MEDWATCH. THE AWARE DATE SHOULD BE (B)(6) 2021.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE APPROVED FINAL INVESTIGATION. 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 DEFINITIVE ROOT CAUSE OF THE FOREIGN MATERIAL COULD NOT BE DETERMINED. HOWEVER, LIKELY CAUSES DUE TO THE FOLLOWING HANDLING OF THE DEVICE: (A) REPROCESSING AROUND THE FORCEPS ELEVATOR AFTER A PROCEDURE WAS INSUFFICIENT, AND / OR (B) THE USER DID NOT REPROCESS THE DEVICE IMMEDIATELY AFTER PROCEDURE, AND FOREIGN MATERIAL ADHERING TO THE FORCEPS ELEVATOR WAS DRIED AND SOLIDIFIED. THE INSTRUCTION MANUAL IDENTIFIES THE FOLLOWING VERBIAGE, WHICH MAY HAVE PREVENTED THE PHENOMENON: ¿3.5 MANUAL CLEANING: BRUSH THE FORCEPS ELEVATOR. THE FOLLOWING DESCRIPTION IS INCLUDED IN IFU (REPROCESSING MANUAL) 3.3 PRECLEANING: IF THE ENDOSCOPE IS NOT IMMEDIATELY CLEANED AFTER EACH PROCEDURE, RESIDUAL ORGANIC DEBRIS WILL BEGIN TO SOLIDIFY AND IT MAY BE DIFFICULT TO EFFECTIVELY REPROCESS THE ENDOSCOPE.". OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AS REPORTED, DEVICE WAS CHECKED AND FOUND REDUCED ANGULATION IN ALL DIRECTIONS. ISSUE FOUND AT MAINTENANCE. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS EVENT. DEVICE RETURN EVALUATION FOUND FOREIGN MATERIAL IN FORCEPS ELEVATOR. THIS REPORT IS BEING SUBMITTED FOR FOREIGN MATERIAL FOUND IN FORCEPS ELEVATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035040 DUODENOVIDEOSCOPE DUODENOVIDEOSCOPE FDT OLYMPUS MEDICAL SYSTEMS CORP. TJF-150 04953170229459

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown