BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE WASHING PIPE

    MDR report key: 11963584 · Received June 9, 2021

    Report

    Report Number
    8010047-2021-07273
    Event Type
    Injury
    Date Received
    June 9, 2021
    Date of Event
    April 30, 2021
    Report Date
    January 12, 2022
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORP.
    Product Code
    OCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO WITHDRAW MFR REPORT #8010047-2021-07273. OLYMPUS CONCLUDED THAT THERE WAS NO MDR REPORTABLE MALFUNCTION OR ADVERSE EVENT.

    Additional Manufacturer Narrative · 0

    THIS IS A SUPPLEMENTAL REPORT TO PROVIDE ADDITIONAL INFORMATION. THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION, BECAUSE THE SUBJECT DEVICE WAS DISCARDED BY THE USER. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE MANUFACTURING RECORD WAS REVIEWED AND FOUND NO IRREGULARITIES. SEARCH WAS CARRIED OUT FOR ANY COMPLAINTS MADE IN WHICH THE SAME PRODUCT LOT BEHAVED THE SAME OR SIMILARLY TO THE REPORTED EVENT. HOWEVER, THERE HAVE BEEN NO REPORT. ALTHOUGH THE ACTUAL DEVICE WAS NOT SENT, IT IS POSSIBLE TO INFER THE CAUSE FROM THE INVESTIGATION RESULTS OF SIMILAR CASES IN THE PAST, SO IT IS UNNECESSARY TO INVESTIGATE USING THE SAME STRUCTURE OF EQUIPMENT AND SIMILAR EQUIPMENT. IT WAS JUDGED. THE SUBJECT DEVICE COULD NOT BE CONFIRMED, AND DHR PRESENTED NO ABNORMALITIES. THEREFORE, THE EXACT CAUSE OF THE CHEMICAL SOLUTION SCATTERING COULD NOT BE DETERMINED. BASED ON SIMILAR COMPLAINTS IN THE PAST, LIKELY FACTORS CAUSING THE CHEMICAL SOLUTION SCATTERING MIGHT BE THE FOLLOWING: *THE INJECTION PORT WAS NOT FULLY CONNECTED TO THE SYRINGE, AND THE CONNECTION WAS LOOSE. *THE STYLET WAS NOT FULLY CONNECTED TO THE PROXIMAL SIDE. THE ABOVE DEVICE HANDLING HAS WARNED IN THE INSTRUCTION MANUAL AS FOLLOWS. *WHEN USING THE INSTRUMENT, ALWAYS WEAR APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT. OTHERWISE, BLOOD, MUCUS AND OTHER POTENTIALLY INFECTIOUS MATERIAL FROM THE PATIENT COULD POSE AN INFECTION CONTROL RISK. APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT MAY INCLUDE: EYE WEAR, A FACE MASK, MOISTURE-RESISTANT CLOTHING AND CHEMICAL-RESISTANT GLOVES THAT FIT PROPERLY AND ARE LONG ENOUGH SO THAT YOUR SKIN IS NOT EXPOSED.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE WAS NOT RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THEREFORE, THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED, IF ADDITIONAL OR SIGNIFICANT INFORMATION BECOMES AVAILABLE AT A LATER TIME.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE HEALTH PROFESSIONAL THAT DURING AN ENDOSCOPY USING THE SUBJECT DEVICE(SPRAY CATHETER), THE FOLLOWING EVENT OCCURRED. WHILE TRYING TO INJECT THE LUGOL WITH THE SUBJECT DEVICE, THE DEVICE WAS DISCONNECTED DUE TO HYPER PRESSURE, AND SOME LUGOL GOT INTO THE USER'S LEFT EYE. THE DEVICE WAS NO LONGER AVAILABLE. THE USER SUFFERED A CORNEAL BURN AND HAD LOCAL TREATMENT. THERE WAS NO SICK LEAVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862983 DISPOSABLE WASHING PIPE WASHING PIPE OCX OLYMPUS MEDICAL SYSTEMS CORP. PW-205V 07K

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other