BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13311622 · Received January 20, 2022

    Report

    Report Number
    9610877-2022-00109
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Report Date
    October 31, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333211692
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE USER FACILITY RESPONDED TO A GOOD FAITH EFFORT REQUEST VIA EMAIL ON 30-DEC-2021 AND NOTED THE USER FACILITY DID NOTIFY THE FDA REGARDING THE EVENT. TTHE PATIENT WAS NOT PREPPED FOR THE PROCEDURE AND THERE WERE NO REPORTED INJURIES OR DELAYS WHICH WOULD REQUIRE MEDICAL INTERVENTION. THE DEVICE WAS REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACEMENT. HE ALSO CONFIRMED THE FACILITY FOLLOWS ALL PRE-PROCEDUREAL CHECKS AND INSTRUCTIONS FOR USE. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 29-DEC-2021. THE ENDOSCOPE WAS RETURNED UNDER SERVICE ORDER 6181085 AND PENDING INSPECTION BY A PENTAX MEDICAL SERVICE TECHNICIAN AS OF 20-JAN-2022. THE INVESTIGATION IS IN-PROCESS. MODEL EG29-I10, SERIAL NUMBER (B)(4) HAS BEEN SERVICED REGULARLY AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. THE INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY. THE DEVICE WAS RETURNED, BUT THE CAUSE COULD NOT BE DETERMINED BECAUSE BASED ON THE INFORMATION OBTAINED AT THIS TIME, IT IS DIFFICULT TO IDENTIFY THE FAILURE PHENOMENON. CORRECTION INFORMATION. G6: FOLLOW UP #1. H2: IF FOLLOW-UP, WHAT TYPE? H6: CODING CHANGED BASED ON THE INVESTIGATION. H4: DEVICE MANUFACTURE DATE.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT WHICH OCCURRED IN THE UNITED STATES WITHIN THE PAI REGION. IN THE EVENT REPORTED, THE CUSTOMER REPORTED NO VIDEO IMAGE INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG29-I10, SERIAL NUMBER (B)(4). THE ISSUE WAS OBSERVED DURING USE IN THE OPERATING ROOM. THERE WAS NO REPORT OF PATIENT INJURY, DELAY IN PROCEDURE OR AN EVENT THAT REQUIRED MEDICAL INTERVENTION. THIS EVENT MEETS THE REQUIREMENT FOR FDA REPORTABILITY; THEREFORE SUBMISSION OF A REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948318 PENTAX VIDEO GASTROSCOPE - I10 STANDARD FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10 04961333211692

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown