BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4.0MM VERSAPOINT RESECTING LOO

    MDR report key: 11646025 · Received April 9, 2021

    Report

    Report Number
    2210968-2021-03221
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    January 30, 2021
    Report Date
    March 11, 2021
    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 · 1

    (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH, AND NO NON-CONFORMANCES WERE IDENTIFIED. PRODUCT RELEASE DATE: APRIL 2020, PRODUCT EXPIRY DATE: APRIL 2025. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DID THE BROKEN PIECE FALL INTO THE PATIENT? IF SO: WAS THE PIECE REMOVED SUCCESSFULLY FROM THE PATIENT? WAS THE PIECE REMOVED DURING THE SAME PROCEDURE? 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. 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 A PATIENT UNDERWENT A HYSTEROSCOPY ON (B)(6) 2021 AND THE ELECTRODE WAS USED. IT WAS REPORTED THAT IN THE SURGICAL FIELD WHEN USING THE LOOP, IT WAS FOUND THAT IT WAS BROKEN. THERE IS ALSO A REPORT THAT THE HANDLE BROKE WHEN REMOVING THE PIECE. THERE WAS NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542329 4.0MM VERSAPOINT RESECTING LOO COAGULATOR-CUTTER, ENDOSCOPIC, BIPOLAR HIH ETHICON INC. UGY2004012

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR