BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12222570 · Received July 24, 2021

    Report

    Report Number
    9610877-2021-10255
    Event Type
    Malfunction
    Date Received
    July 24, 2021
    Date of Event
    April 21, 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
    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 (9610877-2021-10255) 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 (9610877-2021-10255) 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 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-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 USE. THERE WAS NO REPORT OF PATIENT HARM. A THIRD INCIDENT WITH OUR FORCEPS. THEY BREAK SUDDENLY SO BIG PROBLEM TO REMOVE THEM. THEY NEVER SAW FORCEPS TO BREAK. 3 CASES, 3 DOCTORS AND 3 NURSES DIFFERENT. THE FIRST HAD NOT BEEN DECLARED. THE SECOND I MADE THE CLAIM. AND LAST WEEK A THIRD I AWAIT PHARMACIST STATEMENT. BESIDES, THEY REPORT TO ME THAT SINCE OUR FORCEPS THEY HAVE SENT 5 GASTROSCOPES TO REPAIR FOR PERFORMED SHEATH. CHANNEL OP 2.8MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119651 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