BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13191109 · Received January 7, 2022

    Report

    Report Number
    9610877-2022-00023
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    December 10, 2021
    Report Date
    January 15, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333211692
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: CUSTOMER REPORTED NO VIDEO/ERROR MSG, SCOPE NOT CONN. THE CUSTOMER STATED THAT NO ACCESSORY WAS USED DURING THE PROCEDURE AND THERE WERE NO PATIENT/USER INJURIES, ADVERSE EVENTS, DELAY OR MEDICAL INTERVENTION REPORTED. HOWEVER, THERE WAS NO REPAIR DATA THAT COULD DETERMINE THE CAUSE SO WE DIDN'T KNOW WHAT WAS CAUSING IT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED AT PENTAX SERVICE FACILITY FOR FURTHER EVALUATION ON SERVICE ORDER 6181092. THE DEVICE IS CURRENTLY PENDING FURTHER EVALUATION. ON 16-DEC-2021, A DEVICE HISTORY RECORD (DHR) REVIEW FOR MODEL EG29-I10, SERIAL NUMBER (B)(4) WAS PERFORMED AND THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 10FEB2015 UNDER NORMAL CONDITIONS, FAILED FINAL INSPECTION FOR "WELL WORKING OF CURVING" WHERE IT WAS REWORDED AND PASS ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) REGION INVOLVING PENTAX VIDEO SCOPE EG29-I10. IN THE EVENT REPORTED, THE USER STATES THAT THERE WAS NO VIDEO IMAGE. THE TIMING OF THE EVENT WAS IN THE PROCEDURE ROOM DURING USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794436 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG29-I10 04961333211692

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown