BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM VERSAPOINT RESECTING LOO

    MDR report key: 10878399 · Received November 20, 2020

    Report

    Report Number
    2210968-2020-09175
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    January 15, 2020
    Report Date
    October 31, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    HIH
    PMA / PMN Number
    K111751
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT TO FDA: 01/25/2021. H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THE DEVICE HISTORY RECORD FOR BATCH REFERENCED ABOVE WAS REVIEWED FOR NON-CONFORMANCES RELATED TO THE NATURE OF THE COMPLAINT DURING THE MANUFACTURING PROCESS. THE RESULTS OF THIS REVIEW INDICATE THERE WERE ZERO NON-CONFORMANCES REGARDING THE NATURE OF THE COMPLAINT ASSOCIATED WITH THIS LOT. PRODUCT RELEASE DATE: FEBRUARY 2020. PRODUCT EXPIRY DATE: DECEMBER 2024. 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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 · 1

    (B)(4). TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A HYSTEROSCOPY SURGERY FOR MYOMA REMOVAL ON (B)(6) 2020 AND AN ELECTRODE WAS USED. DURING THE PROCEDURE, THE TIP OF THE ELECTRODE BROKE. NO FRAGMENTS WERE GENERATED AND THE PROCEDURE WAS COMPLETED USING A NEW LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339958 4.0MM VERSAPOINT RESECTING LOO COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR HIH ETHICON INC. UGY1912082

    Patients

    Seq Age Sex Outcome Treatment
    1