BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13519138 · Received February 12, 2022

    Report

    Report Number
    9610877-2022-00191
    Event Type
    Malfunction
    Date Received
    February 12, 2022
    Report Date
    October 31, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    UDI-DI
    04961333070909
    PMA / PMN Number
    K951196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE ENDOSCOPE WILL BE EVALUATED BY PENTAX MEDICAL. ONCE EVALUATION IS COMPLETED THE DEVICE WILL BE REPAIRED AND RETURNED TO THE CUSTOMER OR LOANER INVENTORY AS APPLICABLE. MODEL FNL-7RP3, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. ON 01-FEB-2022, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL FNL-7RP3, SERIAL NUMBER (B)(4) WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED IN THE MIYAGI FACILITY ON 31-MAR-2009 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 01-APR-2009. THE INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: G6: FOLLOW UP #1 H2: IF FOLLOW-UP, WHAT TYPE? H3: DEVICE EVALUATED BY MANUFACTURE H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. EVALUATION SUMMARY: WE CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE IMAGE GUIDE FIBER BUNDLE (CFB) WAS BROKEN. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE IMAGE GUIDE FIBER BUNDLE (CFB). IN ADDITION, WE CONFIRMED THAT THE BENDING RUBBER PERFORATED, THE BENDING RUBBER LEAKY, THE ANGLE WIRE BROKEN, THE INSERTION FLEXIBLE TUBE (IFT) CRUSHED, AND THE SEGMENT CRUSHED; HOWEVER, THEY ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES. THE CUSTOMER REPORTED NO VIDEO IMAGE INVOLVING PENTAX MEDICAL FIBER NASO PHARYNGO LARYNOSCOPE, MODEL FNL-7RP3, SERIAL NUMBER (B)(4). THE EVENT TIMING AND LOCATION ARE UNKNOWN. NO DEATH OR SERIOUS INJURY WAS REPORTED. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER SUBMISSION OF THIS 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
    111377 PENTAX FIBER NASO PHARYNGO LARYNGOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE FNL-7RP3 04961333070909

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown