BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12965808 · Received December 8, 2021

    Report

    Report Number
    9610877-2021-01812
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    December 1, 2021
    Report Date
    March 14, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: WE CHECKED THE RETURNED UNIT AND CONFIRMED THE LIGHT GUIDE CABLE LEAKAGE. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE PHYSICAL DAMAGE APPLIED ON THE LIGHT GUIDE CABLE. CORRECTION INFORMATION: G6: FOLLOW UP #1 H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT ADDITIONAL INFORMATION: H4: DEVICE MANUFACTURE DATE.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS NOT MARKETED IN US, THEREFORE 510K IS NOT APPLICABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    LG-CABLE LOOSENED, LEAKY AT CONTROL BODY SIDE. CONNECTING SCREWS LOOSENED. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858561 PENTAX VIDEO COLONOCOPE GCQ HOYA CORPORATION PENTAX TOKYO OFFICE EC-380FK2P

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown