BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WASHING PIPE

    MDR report key: 23175680 · Received September 29, 2025

    Report

    Report Number
    9614641-2025-01629
    Event Type
    Malfunction
    Date Received
    September 29, 2025
    Date of Event
    September 2, 2025
    Report Date
    September 29, 2025
    Manufacturer
    AOMORI OLYMPUS CO., LTD.
    Product Code
    EOB
    PMA / PMN Number
    K013591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION. A ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THE RESULTS OF THE INVESTIGATION, IT IS LIKELY THE FOLLOWING LED TO THE MALFUNCTION: - THE REPORTED EVENT WAS CAUSED BY ADHESIVE BRITTLENESS AND DETACHMENT BETWEEN THE METAL PIPE AND THE PROXIMAL PORTION DUE TO CHEMICAL AGENT EXPOSURE. IT IS INFERRED THAT THE REPORTED EVENT MAY HAVE OCCURRED THROUGH THE FOLLOWING MECHANISM; HOWEVER, THE ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED. 1)INSUFFICIENT RINSING DURING REPROCESSING MAY HAVE ALLOWED CHEMICAL AGENTS OR OTHER SUBSTANCES TO REMAIN ON THE ADHESIVE. 2)THE AUTOCLAVE PROCESS WAS CARRIED OUT WHILE CHEMICAL AGENTS REMAINED ADHERED TO THE ADHESIVE. 3)THROUGH REPEATED EXECUTION OF THE ABOVE STEPS (1¿2), THE ADHESIVE BECAME BRITTLE DUE TO THE INFLUENCE OF CHEMICAL AGENTS, RESULTING IN PARTIAL DETACHMENT. CONSEQUENTLY, FLUID LEAKAGE OCCURRED FROM THE DETACHED AREA. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. THE EVENT CAN BE DETECTED/PREVENTED BY FOLLOWING THE INSTRUCTIONS FOR USE WHICH STATE: A REVIEW WAS PERFORMED USING THE IFU. NO ANOMALIES WERE FOUND. -WAS IT USED IN ACCORDANCE WITH THE IFU/LABEL? THE COMPLAINT INFORMATION DID NOT CLARIFY WHETHER THE PRODUCT WAS USED ACCORDING TO THE IFU. -DOES THE IFU/LABEL NEED TO BE REVISED OR WAS THERE AN ISSUE WITH TRANSLATION, WORDING, OR GRAPHICS? NO. -IS THE REPORTED RISK/HARM LISTED IN THE IFU? YES. UPON REVIEWING THE IFU, THE FOLLOWING STATEMENTS RELEVANT TO THIS EVENT WERE FOUND. DRAWING NUMBER AND REVISION NUMBER OF IFU: GW7324 18 IF ANY ABNORMALITIES ARE SUSPECTED WHILE USING THIS PRODUCT, DISCONTINUE USE IMMEDIATELY. IF YOU ARE UNSURE HOW TO ADDRESS THE ISSUE, PLEASE CONTACT OLYMPUS DO NOT APPLY EXCESSIVE BENDING, PULLING, OR PRESSURE TO THIS PRODUCT. DOING SO MAY CAUSE DAMAGE OR IMPAIR ITS FUNCTIONALITY. DO NOT COIL THE INSERTION PORTION WITH A DIAMETER OF LESS THAN 15 CM. THIS COULD DAMAGE THE INSERTION PORTION. BEFORE EACH CASE, PREPARE AND INSPECT THE INSTRUMENT AS INSTRUCTED BELOW. INSPECT OTHER EQUIPMENT TO BE USED WITH THE INSTRUMENT AS INSTRUCTED IN THEIR RESPECTIVE INSTRUCTION MANUALS. SHOULD THE SLIGHTEST IRREGULARITY BE SUSPECTED, DO NOT USE THE INSTRUMENT; CONTACT OLYMPUS. DAMAGE OR IRREGULARITY MAY COMPROMISE PATIENT OR USER SAFETY, SUCH AS INFECTION CONTROL RISK, TISSUE IRRITATION, PUNCTURES, HEMORRHAGES, MUCOUS MEMBRANE DAMAGE OR THERMAL INJURY AND MAY RESULT IN MORE-SEVERE EQUIPMENT DAMAGE. DO NOT USE THE INSTRUMENT IF FLUID CANNOT BE INJECTED OR IF IT LEAKS FROM ANY AREAS OTHER THAN THE DISTAL END. IN THIS CASE, USE A SPARE INSTEAD. PATIENT DEBRIS AND REPROCESSING CHEMICALS ARE HAZARDOUS. WEAR PERSONAL PROTECTIVE EQUIPMENT TO GUARD AGAINST DANGEROUS CHEMICALS AND INFECTIOUS MATERIAL. DURING CLEANING AND STERILIZATION, ALWAYS WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT, SUCH AS EYE WEAR, FACE MASK, MOISTURE-RESISTANT CLOTHING AND CHEMICAL-RESISTANT GLOVES THAT FIT PROPERLY AND ARE LONG ENOUGH SO THAT YOUR SKIN IS NOT EXPOSED. ALWAYS REMOVE CONTAMINATED PROTECTIVE CLOTHING BEFORE LEAVING THE REPROCESSING AREA. WHEN CLEANING, AVOID EXPOSE TO THE FLUIDS FROM THE INSERTION PORTION AND REPROCESSING CHEMICALS. THEY MAY CAUSE AN INFECTION CONTROL RISK OR POSE SKIN IRRITATION. WHEN REPROCESSING, DO NOT COIL THE INSERTION PORTION AND STYLET¿S WIRE WITH A DIAMETER OF LESS THAN 15 CM. THIS COULD DAMAGE TO THE INSERTION PORTION AND STYLET¿S WIRE. RINSING 1. CONNECT A 10 CM3 (10 ML) SYRINGE FILLED WITH CLEAN TAP WATER TO THE INJECTION PORT. 2. COVER THE PROXIMAL END WITH YOUR FINGER (EXPECT WHEN USING PW-7SX-1) AND INJECT 10 CM3 (10 ML) OF WATER INTO THE INSERTION PORTION. IF IT IS NOT POSSIBLE TO INJECT WATER OR IF IT LEAKS FROM ANY PART OTHER THAN THE DISTAL END OF THE INSERTION PORTION, DO NOT USE THE INSTRUMENT. 3. DISCONNECT THE SYRINGE FROM THE INJECTION PORT. 4. REPEAT STEPS 1. THROUGH 3. TO INJECT A TOTAL OF 20 CM3 (20 ML) OF WATER INTO THE INSERTION PORTION. 5. RINSE THE TUBE SHEATH AND STYLET UNDER CLEAN RUNNING TAP WATER. 6. CONFIRM THAT NO DEBRIS IS LEFT ON THE SURFACES OF THE TUBE SHEATH AND STYLET. 7. CONNECT A 10 CM3 (10 ML) SYRINGE FILLED WITH AIR TO THE INJECTION PORT. 8. INJECT 10 CM3 (10 ML) OF AIR INTO THE INSERTION PORTION. 9. DISCONNECT THE SYRINGE FROM THE INJECTION PORT. 10. REPEAT STEPS 7. THROUGH 9. UNTIL NO LIQUID APPEARS FROM THE DISTAL END OF THE INSERTION PORTION STEAM STERILIZATION (AUTOCLAVING) 1. PLACE THE SEALED PACKAGES CONTAINING THE INSTRUMENT IN THE AUTOCLAVE AND STERILIZE IN ACCORDANCE WITH THE CONDITIONS LISTED BELOW. FOR DETAILS ON OPERATION OF THE AUTOCLAVE, REFER TO THE INSTRUCTION MANUAL FOR THE AUTOCLAVE OR OTHER MANUFACTURER INSTRUCTIONS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE WASHING PIPE EXHIBITED POWDER-LIKE FOREIGN MATTER ADHERED TO THE PEELED ADHESIVE AREA. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839301 WASHING PIPE WASHING PIPE EOB AOMORI OLYMPUS CO., LTD. PW-6P-1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown