BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 20104022 · Received August 29, 2024

    Report

    Report Number
    9610877-2024-00082
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 7, 2024
    Report Date
    October 24, 2024
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    QNP
    UDI-DI
    04961333247493
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 UDI: "NOT DISTRIBUTED IN USA", BECAUSE PRODUCTS ARE NO DISTRIBUTED IN USA PRODUCTS, BUT SIMILAR DEVICE PRODUCT IS LISTED IN USA. G4: THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. INVESTIGATION IS IN-PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. FILE ATTACHMENTS.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION B4: DATE OF THIS REPORT D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # G6: FOLLOW UP #1 H2: IF FOLLOW-UP, WHAT TYPE? H3: DEVICE EVALUATED BY MANUFACTURE H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT. ADDITIONAL INFORMATION H4: DEVICE MANUFACTURE DATE. EVALUATION SUMMARY BASED ON THE INVESTIGATION, A POTENTIAL ROOT CAUSE OF THIS FAILURE IS THE SYSTEM CONTROL PCB FAILURE OR THE SHORT OF POWER SUPPLY UNIT. A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE IDENTIFIED. THE DEVICE HAS BEEN REPLACED. THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 26-AUG-2022 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS AND WAS RELEASED ACCORDINGLY. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    COVER OF THE NEW SAS-M10 MONITOR SMOKED DURING SWITCH ON THE FIRST TIME 08-AUG-2024_WE ASKED FOR FURTHER INFORMATION AND PICTURES NO FURTHER INFORMATION. TEH MONITOR WAS SWITCHED OFF AND SEND BACK TO PENTAX MEDICAL EMEA FOR REPLACEMENT. THIS EVENT OCCURRED AT THE TIME OF INSTALLATION. 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
    1912123 PENTAX SMART ASSISTANT SYSTEM QNP HOYA CORPORATION PENTAX TOKYO OFFICE SAS-M10 04961333247493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown