BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 14452913 · Received May 20, 2022

    Report

    Report Number
    2518897-2022-00207
    Event Type
    Injury
    Date Received
    May 20, 2022
    Report Date
    May 19, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    UDI-DI
    04961333221325
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MODEL IS CLASSIFIED AS IMPORT FOR EXPORT AND NOT DISTRIBUTED IN THE UNITED STATES, THEREFORE 510K IS NOT APPLICABLE. WE DO HAVE SIMILAR MODEL EC38-I10L-US AVAILABLE IN THE UNITED STATES WITH A 510K NUMBER K131855. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 01-APR-2022. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER WORK ORDER (B)(4) AND THE SERVICE TECHNICIAN WAS ABLE TO CONFIRM THE CUSTOMER COMPLAINT AND DOCUMENTED THE FOLLOWING INSPECTION FINDINGS: SCOPE LEAK TEST : DRY LEAK TEST FAIL, SCOPE ELECTRICAL TEST FUNCTION: DST ELECTRICAL SAFETY TEST FAIL, SCOPE ELECTRICAL TEST FUNCTION: PLCT ELECTRICAL SAFETY TEST FAIL, INSERTION FLEXIBLE TUBE: CRUSHED, INSERTION FLEXIBLE TUBE: FLUID DAMAGE, INSERTION FLEXIBLE TUBE: LEAK, INSERTION FLEXIBLE TUBE: PERFORATED, BENDING RUBBER: WORN OUT, ROOT BRACE RUBBER (INSERTION FLEXIBLE TUBE): CRACKED, REMOTE CONTROL BUTTON(1): CUT, CONTROL BODY: FLUID DAMAGE, CONTROL BODY: CORRODED, U/D KNOB: BROKEN. THE ENDOSCOPE WAS REPAIRED AND THE WORK ORDER WAS CLOSED ON 28-APR-2022 AND WAS DELIVERED TO THE CUSTOMER. ON 22-APR-2022, A DEVICE HISTORY RECORD(DHR) REVIEW FOR MODEL VNL11-J10, SERIAL NUMBER (B)(4) WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED IN THE MIYAGI FACILITY ON 12-DEC-2018 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 12-DEC-2018. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. MDR 9610877-2022-00482 WAS SUBMITTED ON BEHALF OF THE MANUFACTURER ON 19-APR-2022.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT THAT OCCURRED IN THE UNITED STATES. THE CUSTOMER REPORTED PATIENT PAIN INVOLVING PENTAX MEDICAL VIDEO NASO PHARYNGO LARYNGOSCOPE MODEL VNL11-J10, SERIAL NUMBER (B)(4). THE USER ALSO NOTED THAT "THE ENDOSCOPE FAILED DRY AND WET LEAK TEST. HOLE RESIDES ON THE RUBBER TUBING CLOSEST TO THE SCOPE HANDLE ITSELF. AT THE DISTAL MOST END OF THE INSERTION TUBE, THE RUBBER STARTED TO BUNCH UP CAUSING A SLIGHT MUSHROOMING OF THE RUBBER. PATIENTS REPORT PAIN AND SCOPE WAS TAKEN OUT OF SERVICE." 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
    2319434 PENTAX VIDEO NASO PHARYNGO LARYNGOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL11-J10 04961333221325

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other