BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON COATED PNCL BTN HLSTR

    MDR report key: 12482385 · Received September 16, 2021

    Report

    Report Number
    1721194-2021-00071
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    July 26, 2021
    Report Date
    October 26, 2021
    Manufacturer
    MEGADYNE MEDICAL PRODUCTS, INC.
    Product Code
    GEI
    UDI-DI
    10614559100868
    PMA / PMN Number
    K965054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/26/2021. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON ENDO SURGERY FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. THE DEVICE WAS RETURNED WITH NO APPARENT DAMAGE. THE DEVICE WAS FUNCTIONALLY TESTED WITH A MULTIMETER AND MEETS THE SPECIFICATION, NO ABNORMALITIES WERE OBSERVED. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE WAS RETURNED WITHOUT DETECTABLE DAMAGE. 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. AS PART OF ETHICON ENDO SURGERY QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE BATCH HISTORY RECORDS WERE REVIEWED AND CERTIFIED BY EXTERNAL MANUFACTURING THAT THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE EQUIPMENT. THE CERTIFICATE RECORDS ARE ACCESSIBLE THROUGH EXTERNAL MANUFACTURING.

    Additional Manufacturer Narrative · 0

    (B)(4), DATE SENT: 10/5/2021 ADDITIONAL INFORMATION RECEIVED: NEW DEANTRONICS STATED: THE DHR REVIEW IS CONFIRMED THAT THE PRODUCT WAS PRODUCED ACCOMPLISHING QUALITY REQUIREMENTS AND RELEASED ACCORDING TO ESTABLISHED PROCEDURES.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE THREW OFF THE ELECTRIC SPARKS. NEXT (B)(6) MEDICALNEXT¿S ELECTRIC KNIFE WAS USED WITH THE DEVICE. THE SETTING VOLTAGE WAS 45·45, 40·40 WHEN IT SPARKED. COMPETITIVE GENERATOR WAS USED. 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
    1380546 NON COATED PNCL BTN HLSTR NON COATED PENCIL BUTTON HOLSTER GEI MEGADYNE MEDICAL PRODUCTS, INC. 0039H 1807220 10614559100868

    Patients

    Seq Age Sex Outcome Treatment
    1