BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12350589 · Received August 20, 2021

    Report

    Report Number
    9610877-2021-00709
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    February 22, 2021
    Report Date
    December 15, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. HOWEVER SIMILAR MODEL IS SOLD IN THE UNITED STATES ED34-I10T2-US WITH 510K- K192245. (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. THIS COMPLAINT IS BEING PROCESSED IN ACCORDANCE WITH DPA-QIP-MDR DECISION BACKLOG MANAGEMENT PLAN.

    Additional Manufacturer Narrative · 0

    UPDATED SECTIONS: B4: DATE OF THIE REPORT, G3: DATE RECEIVED BY MANUFACTURER, G6: TYPE OF REPORT: FOLLOWUP 01 AND H10. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) REGION INVOLVING PENTAX VIDEO COLONOSCOPE ED34-I10T2. IN THE EVENT REPORTED, IT WAS STATED THAT THERE IS POTENTIAL ENDOSCOPE CONTAMINATION -THESE SCOPES ARE ALL BEING SENT IN FOR DELAYED REPROCESSING. THESE ARE ALL DUE TO LAST WEEKS WINTER STORM THAT DEVASTATED (B)(6). ALL THESE SCOPES HAVE BEEN SITTING FOR 72+ HOURS WITHOUT BEING PROPERLY HIGH LEVEL DISINFECTED. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT THE DEVICE WAS RETUNED TO PENTAX MEDICAL SERVICE CENTER FOR FURTHER EVALUATION ON SERVICE ORDER (B)(4) WHERE IT WAS REPROCESSED AND INSPECTED. THE INSPECTION FINDINGS ARE AS FOLLOWS: AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, PASSED WET LEAK TEST, PASSED DRY LEAK TEST. THE DEVICE WAS CULTURED AND REPAIRED AND RETURNED TO THE USER ON DELIVERY (B)(4). PARTS REPLACED: O-RINGS AND SEALS, BENDING RUBBER, AIR/WATER TUBE, OPERATION CHANNEL, SUCTION CHANNEL LG, AIR/WATER SUPPLY TUBE LG, O-RING(0.5X1.3) IMP-1, BIOPSY INLET T-PIECE PB-FREE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL.

    Description of Event or Problem · 0

    REFER TO H10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1246835 PENTAX DEC HD VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown