BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 17643683 · Received August 29, 2023

    Report

    Report Number
    2518897-2023-00042
    Event Type
    Injury
    Date Received
    August 29, 2023
    Date of Event
    August 15, 2023
    Report Date
    November 7, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    UDI-DI
    04961333221325
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    F10 CONTINUED: INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING. HEALTH EFFECT CLINICAL CODE: 2330 DISCOMFORT. HEALTH EFFECT IMPACT CODE: 2199 NO HEALTH CONSEQUENCES OR IMPACT. MEDICAL DEVICE PROBLEM CODE: 3000 OPTICAL DISTORTION, 2999 OPTICAL DISCOLORATION; 3026 UNINTENDED MOVEMENT. COMPONENT CODE: 525 TUBE, 841 IMAGER. PENTAX MEDICAL AMERICA INC. PERFORMED GOOD FAITH EFFORT TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT. ON 16-AUG-2023, THE USER FACILITY PROVIDED AN EMAIL RESPONSE STATING "THERE WAS NO SPECIFIC PATIENT INJURY OR AE[ADVERSE EVENT]; PATIENTS JUST MENTIONED THAT THE SCOPES WERE UNCOMFORTABLE. B2: OTHER SERIOUS OR IMPORTANT MEDICAL EVENTS" WAS SELECTED SINCE THE USER GOOD FAITH EFFORT RESPONSE DETAILED THE UNCOMFORTABLE PATIENT. 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: BASED ON THE DATA FROM THE INVESTIGATION, IT WAS DETERMINED THAT THE POTENTIAL/ROOT CAUSE OF THE FAILURE WAS DUE TO THE DETERIORATION OF THE BENDING RUBBER MATERIAL DUE TO LONG-TERM USE (4 YEARS AND 10 MONTHS). THE BENDING RIUBBER, ITEM NUMBER C246-SA110, WAS REPLACED ON 21-AUG-2023 VIA WORK ORDER (B)(4). THE DEVICE REPAIR WAS COMPLETED ON 28-AUG-2023. A DEVICE HISTORY RECORD(DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED AT THE PENTAX MEDICAL MIYAGI SITE ON 03-OCT-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 ON 03-OCT-2018. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED. IMPORTER MDR 2518897-2023-00042, (B)(6) 2023 PROCEDURE PATIENT 01. IMPORTER MDR 2518897-2023-00043, (B)(6) 2023 PROCEDURE PATIENT 02.

    Description of Event or Problem · 0

    ON 15-AUG-2023, PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT INVOLVING A VIDEO ENT SCOPE, MODEL VNL11-J10, SERIAL NUMBER (B)(6). THE CUSTOMER INITIALLY REPORTED "HAVE BUNCHING AT THE DISTAL TIP OF EACH SCOPE. THE LIGHT OUTPUT AND COLORS SEEM TO BE OFF AS WELL." CUSTOMER CLARIFIED THAT THERE WAS NO SPECIFIC PATIENT INJURY OR AE; PATIENTS JUST MENTIONED THAT THE SCOPES WERE UNCOMFORTABLE. PER THE TERRITORY MANAGER FOR THIS FACILITY, THE COMMUNITY AT LARGE KNOWS THAT WHEN THE RUBBER ON THE INSERTION TUBE MUSHROOMS OUT FROM MUCH USE AND/OR REPROCESSING, IT COULD CAUSE DISCOMFORT TO THE PATIENT. 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.

    Description of Event or Problem · 0

    REFER TO H10.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958547 PENTAX VIDEO NASO PHARYNGO LARYNGOSCOPE EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL11-J10 04961333221325

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other