BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222551 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10227
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    April 29, 2021
    Report Date
    September 15, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    GCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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 (9610877-2021-10227) WHICH WAS SUBMITTED ON JULY 24, 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 (9610877-2021-10227) WHICH WAS SUBMITTED ON JULY 24, 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 CLASSIFIED AS IMPORT FOR EXPORT, THEREFORE 510K IS NOT APPLICABLE. MODEL KA-2415S IS AVAILABLE IN THE USA WITH 510K NUMBER K951198. LOT NUMBER IS UNAVAILABLE. EVALUATION SUMMARY: IT WAS CAUSED DUE TO AN EXCESSIVE FORCE APPLIED ON THE FORCE DURING USE. 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 DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. FOLLOWING A TEST ON A BRAND NEW BIOPSY FORCEPS COMING OUT OF STOCK FOR INVESTIGATION, THE PULLING WIRE DETACHED FROM ITS ATTACHMENT ON THE SLIDER. THE IMPACT IS THAT FORCEPS JAWS REMAIN IRRETRIEVABLY OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119617 PENTAX FORCEPS TOOTHEDCUP REUSE 2.4DIA 150L GCL HOYA CORPORATION PENTAX TOKYO OFFICE VDK-FB-23-230-O-P-A1

    Patients

    Seq Age Sex Outcome Treatment
    1