BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 8546915 · Received April 24, 2019

    Report

    Report Number
    9610877-2019-00271
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    October 13, 2018
    Report Date
    March 27, 2019
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PMA/510K: PENTAX MODEL KW-D2423T IS NOT SOLD IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. (B)(4). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A REPORT ON 27MAR2019 FOR AN EVENT WHICH OCCURRED IN THE OPERATING ROOM DURING USE AT (B)(6) HOSPITAL IN (B)(6). THE REPORTED COMPLAINT STATED, "FORCEP TOOK TOO BIG A CHUNK WITH SAMPLE AND SPECIALIST WAS CONCERNED IT CAUSED TOO MUCH DAMAGE WHILST SAMPLING", INVOLVING PENTAX MEDICAL BIOPSY FORCEPS WITH WINDOW FOR WILSON, MODEL KW-D2423T, LOT NUMBER 170713. ON 04APR2019, PENTAX MEDICAL AMERICA REQUESTED ADDITIONAL EVENT DETAILS AND RECEIVED THE RESPONSE STATING THAT THERE WAS NO PATIENT INJURY OR ADVERSE EVENT AND NO DELAY IN THE PROCEDURE WHICH WOULD REQUIRE MEDICAL INTERVENTION SUCH AS ADDITIONAL ANESTHESIA OR A PROLONG HOSPITAL STAY. AN UPDATE TO THE PATIENT CURRENT STATUS WAS NOT PROVIDED BUT THE PATIENT WAS NOT BEING RECALLED FOR FURTHER SCREENING. PATIENT INFORMATION WAS NOT PROVIDED PER HIPPA GUIDELINES. THE INVESTIGATION IS IN-PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337849 PENTAX FORCEPS FDS HOYA CORPORATION PENTAX TOKYO OFFICE KW-D2423T 170713

    Patients

    Seq Age Sex Outcome Treatment
    1