BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12250858 · Received July 30, 2021

    Report

    Report Number
    9610877-2021-10328
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    April 4, 2021
    Report Date
    September 15, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    GCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PENTAX INTERNAL REVIEW IT WAS DISCOVERED ON SEPTEMBER 6, 2021 THAT THE EVENT WAS NOT REPORTABLE BUT FILED UNDER MDR (9610877-2021-10328) WHICH WAS SUBMITTED ON JULY 30, 2021. THIS PRODUCT IS NOT REPORTABLE BECAUSE OF OEM PRODUCTS. PENTAX HAS FORWARDED THIS COMPLAINT TO THE LEGAL MANUFACTURER. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 0

    DURING PENTAX INTERNAL REVIEW IT WAS DISCOVERED ON SEPTEMBER 6, 2021 THAT THE EVENT WAS NOT REPORTABLE BUT FILED UNDER MDR (9610877-2021-10328) WHICH WAS SUBMITTED ON JULY 30, 2021. THIS PRODUCT IS NOT REPORTABLE BECAUSE OF OEM PRODUCTS. PENTAX HAS FORWARDED THIS COMPLAINT TO THE LEGAL MANUFACTURER. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL KA-1815S IS AVAILABLE IN THE USA WITH A 510K NUMBER K951198. EVALUATION SUMMARY: IT WAS CAUSED DUE TO AN EXCESSIVE FORCE APPLIED ON THE CAP. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. WHEN THE PRODUCT WAS OPENED AND CONFIRMED WHEN IT WAS USED AT THE FACILITY, THE OPENING AND CLOSING OPERATION WAS NOT SUCCESSFUL, SO THE USE WAS DISCONTINUED AND TREATMENT WAS CONTINUED WITH ANOTHER PRODUCT. IN ADDITION, SINCE DEFECTS WERE CONFIRMED IN THE PRE-USE INSPECTION, NO HEALTH DAMAGE HAS OCCURRED TO PATIENTS OR HEALTHCARE PROFESSIONALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1153288 PENTAX FORCEPS TOOTHEDCUP REUSE 1.8DIA 150L GCL HOYA CORPORATION PENTAX TOKYO OFFICE VDK-FB-18-160-O-P-A1P

    Patients

    Seq Age Sex Outcome Treatment
    1