BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENEW XR HANDPIECE, 34CM, REUSABLE

    MDR report key: 21179271 · Received January 17, 2025

    Report

    Report Number
    1223422-2024-00043
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    August 1, 2024
    Report Date
    January 17, 2025
    Manufacturer
    MICROLINE SURGICAL INC
    Product Code
    GEI
    UDI-DI
    00811099013761
    PMA / PMN Number
    K234147
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE REQUESTS FROM MICROLINE SURGICAL, THE ASSOCIATED PRODUCT WAS NOT RETURNED TO MSI FOR INVESTIGATION WITHIN 30+ DAYS. THIS COMPLAINT WILL BE CLOSED PER PMF-Q3-003. IF THE ITEM IS RETURNED, THE COMPLAINT RECORD WILL BE REOPENED AND INVESTIGATED.

    Description of Event or Problem · 0

    WHILE OPERATING IN THE ABDOMINAL CAVITY A BURN ON OVARIAN TISSUE WAS NOTICED BY SURGEONS. THEY STATED THEY HAD THE DISP. SCISSOR TIP ON THE MICROLINE PISTOL HANDLE IN VIEW AT ALL TIMES AND DIDN'T SEE IT TOUCH THE TISSUE THAT APPEAR TO HAVE THE SCORCH MARK ON IT. INSTRUMENT WAS MARKED AND LABELED AS BROKEN; PLACED BACK IN THE TRAY FOR PROCESSING. PROCESSING CENTER INDICATES THAT THIS WAS PROCESSED PER PROCEDURE AND PASSED ALL QUALITY TEST OF LAPAROSCOPIC EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017522 RENEW XR HANDPIECE, 34CM, REUSABLE LAPAROSCOPIC, HANDPIECE GEI MICROLINE SURGICAL INC 3941 00811099013761

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female