BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    E-Z CLN PNL BTN MOD BD HLR BNS

    MDR report key: 18985865 · Received March 27, 2024

    Report

    Report Number
    1721194-2024-00034
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    February 5, 2024
    Report Date
    April 18, 2024
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559103517
    PMA / PMN Number
    K965054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 4/10/2024 ADDITIONAL INFORMATION RECEIVED: THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PROCEDURE: HEPATECTOMY WHEN THE EVENT OCCURRED: IN USE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 3/27/2024. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. LOT NUMBER WAS RECEIVED AND DHR IS PENDING REVIEW. WHEN THE REVIEW IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT WITH A SUMMARY OF THE EVALUATION. ADDITIONAL INFORMATION RECEIVED: THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. PROCEDURE: HEPATECTOMY WHEN THE EVENT OCCURRED: IN USE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/18/2024. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLES REVEALED THAT THE 0037HBN DEVICES WERE RECEIVED WITH NO APPARENT DAMAGE. THE DEVICE WAS CONNECTED TO THE GENERATOR AND IT WORKED AS INTENDED. THERE WERE NO ANOMALIES NOTED WITH THE FUNCTIONALITY OF THE DEVICE. THE INSTRUMENT WAS TESTED FOR CONTINUITY BY PRESSING THE COAG AND CUTTING BUTTONS AND NO ANOMALIES WERE NOTED WITH THE FUNCTIONALITY OF THE DEVICE. ADDITIONALLY, A PHOTO WAS PROVIDED AND SHOWED THE CONDITION OF THE REPORTED EVENT. AS PART OF ETHICON ENDO SURGERY QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT: 2202285, AND NO NON-CONFORMANCE'S WERE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A HEPATECTOMY PROCEDURE, THE DEVICE FUNCTIONED ALTHOUGH THE BUTTON WAS NOT PRESSED. THIS DEVICE WAS INCLUDED IN THE KIT PACK ¿OPERA MASTER¿. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494351 E-Z CLN PNL BTN MOD BD HLR BNS E-Z CLEAN PENCIL BTN MOD BLADE HLSTR BNS GEI MEGADYNE MEDICAL PRODUCTS, INC. 2202285 10614559103517

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown