BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 11988815 · Received June 12, 2021

    Report

    Report Number
    2518897-2021-00131
    Event Type
    Injury
    Date Received
    June 12, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 2, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SUMMARY: AFTER RETURNING THIS ENDOSCOPE, IT WAS INSPECTED AND THE OTHER TWO SCREWS WERE FOUND IN PMK BY THE SERVICE TEAM. PENTAX R&D TEAM HAS STARTED INVESTIGATION FOR THIS ISSUE(BENDING RUBBER PEEL OFF AND LOOSED SCREWS) BUT ROOT CAUSE IS NOT DETERMINED AS OF NOW BECAUSE RE-CREATION IS IMPOSSIBLE THROUGH THEIR ACTIVITIES. THEREFORE WE COULD PROVIDE NO SPECIAL RECOMMENDATION TO AVOID/MITIGATE FAILURE. WEAR WAS SELECTED AS THE MOST APPROPRIATE INVESTIGATION CODE. REPLACING BELOW SPARE PART: Q010-U5020 SEGMENT STAYCOIL ASSY 1 AND D965-SA038 BENDING RUBBER 1. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS INFORMED OF AN EVENT ON (B)(6) 2021 THAT OCCURRED IN SOUTH KOREA WITHIN THE APAC REGION DURING USE. THE INFORMATION PROVIDED INDICATED THAT DURING THE ENDOSCOPY THE BENDING RUBBER BURST AND A SCREW FELL OUT. THE ENDOSCOPE WAS WITHDRAWN RIGHT AWAY, AND ANOTHER ENDOSCOPE WAS INSERTED TO REMOVE THE SCREW THAT FELL OUT INVOLVING PENTAX MEDICAL VIDEO GASTROSCOPE, MODEL EG29-I10C, SERIAL NUMBER (B)(4). AFTER RETURNING THIS ENDOSCOPE, IT WAS INSPECTED AND THE OTHER TWO SCREWS WERE FOUND OUT IN PMK BY THE SERVICE TEAM. CURRENTLY THE ENDOSCOPE IS AWAITING REPAIR. THE INVESTIGATION IS IN-PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885111 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention