BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 10293539 · Received July 19, 2020

    Report

    Report Number
    9610877-2020-00111
    Event Type
    Malfunction
    Date Received
    July 19, 2020
    Report Date
    June 19, 2020
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333129492
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. SUCTION ISSUE. THE FOLLOWING RELATED MDRS WERE FILED FOR THIS EVENT: MODEL: EG-2990I, SERIAL NUMBER: (B)(4), PENTAX MEDICAL FILED MFR REPORT NUMBER 9610877-2020-00104 MODEL: EG-2990I, SERIAL NUMBER: (B)(4), PENTAX MEDICAL FILED MFR REPORT NUMBER 9610877-2020-00111 MODEL: EC-3890LI, SERIAL NUMBER: (B)(4), PENTAX MEDICAL FILED MFR REPORT NUMBER 9610877-2020-00112 MODEL: EC-3890LI, SERIAL NUMBER: (B)(4), PENTAX MEDICAL FILED MFR REPORT NUMBER 9610877-2020-00113.

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 01-JUL-2020 FOR THE STICKING ANDORATE DISPOSABLE VALVES THAT OCCURRED DURING A PROCEDURE ON, OR AROUND (B)(6), 2020. NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER, OR DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION WAS REPORTED. ANDORATE DISPOSABLE VALVE MODEL AND SERIAL NUMBERS: MODEL: GAR081P - LOT: 19121608 AND (B)(4). THE MODEL AND SERIAL NUMBERS OF THE PENTAX MEDICAL ENDOSCOPES USED BY THE FACILITY ON OR AROUND JUNE 8, 2020 WERE RECEIVED FROM THE SALES REP ON 13-JUL-2020: MODEL: EG-2990I, SERIAL NUMBER: (B)(4). MODEL: EG-2990I, SERIAL NUMBER: (B)(4). MODEL: EC-3890LI, SERIAL NUMBER: (B)(4). MODEL: EC-3890LI, SERIAL NUMBER: (B)(4). BASED ON A PHONE CALL ON (B)(6) 2020, IT WAS CONFIRMED THAT ALL OF THE ABOVE MODEL/SERIAL NUMBERS HAD SUCTION FAILURES WITH ANDORATE DISPOSABLE VALVES DURING PROCEDURES ON OR AROUND , 2020.(B)(4). THE SPECIFIC PROCEDURE DATES, ASSOCIATED PENTAX MEDICAL ENDOSCOPES USED DURING EACH PROCEDURE, AND PATIENT INFORMATION WERE NOT PROVIDED TO PENTAX MEDICAL AND ARE NOT GOING TO BE AVAILABLE. ON 17-JUL-2020, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL: EG-2990I, SERIAL NUMBER: (B)(4) WAS PERFORMED UNDER IVAI-20-070045, THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 18-MAY-2012 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED FOR 18-MAY-2012. PENTAX MODEL: EG-2990I, SERIAL NUMBER: (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 10-JUL-2012. THE PENTAX MEDICAL VIDEO GASTROSCOPE HAS NOT BEEN RETURNED TO PENTAX MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757838 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2990I 04961333129492

    Patients

    Seq Age Sex Outcome Treatment
    1