BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 18735969 · Received February 19, 2024

    Report

    Report Number
    9610877-2024-00014
    Event Type
    Malfunction
    Date Received
    February 19, 2024
    Date of Event
    January 25, 2024
    Report Date
    April 17, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333226153
    PMA / PMN Number
    K192245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENTAX MEDICAL AMERICA PERFORMED GOOD FAITH EFFORT TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT, HOWEVER THEY ARE UNABLE TO OBTAIN IT AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. MANUFACTURER MDR 9610877-2024-00013, DUODENOSCOPE MODEL:ED34-I10T2, SERIAL:UNKNOWN, DEC DISTAL CAP MODEL OE-A63 LOT NUMBER 0011112 MANUFACTURER MDR 9610877-2024-00015, DEC DISTAL CAP MODEL OE-A63 LOT NUMBER 0011112.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY THE FACILITY DID NOT RESPOND TO THE GFE(GOOD FAITH EFFORT) . BASED ON THE INVESTIGATION, SINCE SIMILAR PROBLEMS DID NOT OCCUR FREQUENTLY AT OTHER FACILITIES, WE DETERMINED THAT IT WAS A USER ERROR, BUT WE WERE UNABLE TO DETERMINE THE CAUSE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 24-OCT-2022 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT ON 04-NOV-2022 AND ACTUAL DATE SHIPPED WERE CONFIRMED ON 07-NOV-2022. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    PER THE INITIAL REPORT, THE FIRST CAP[DEC] CLICKED ON BUT DETACHED BEFORE PATIENT USE, SECOND CAP[DEC] CLICKED ON BUT THEN DETACHED BEFORE PATIENT USE, THIRD CAP[DEC] ATTACHED AND WAS USED FOR A CASE AND HAD DIFFICULTIES REMOVING FROM THE ENDOSCOPE. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY; HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098926 PENTAX STERILE DISTAL END CAP FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 04961333226153

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown