BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12349508 · Received August 20, 2021

    Report

    Report Number
    9610877-2021-00705
    Event Type
    Malfunction
    Date Received
    August 20, 2021
    Date of Event
    February 22, 2021
    Report Date
    August 20, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 EG34-I10-US WITH 510K- K180292. (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.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE PAI REGION INVOLVING PENTAX VIDEO COLONOSCOPE EC34-I10L. 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 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 O-RINGS AND SEALS DISTAL END ASSY WITH TUBES ADJUSTING COLLAR BENDING RUBBER BIOPSY INLET T-PIECE PB-FREE ANGLE WIRE ASSY SUCTION CHANNEL LG JET SUPPLY TUBE LG AIR/WATER SUPPLY TUBE LG

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247080 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG34-I10

    Patients

    Seq Age Sex Outcome Treatment
    1