BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RD180 SUTURING DEVICE

    MDR report key: 13077103 · Received December 22, 2021

    Report

    Report Number
    MW5106247
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    December 17, 2021
    Report Date
    December 20, 2021
    Manufacturer
    LSI SOLUTIONS, INC.
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT IN OPERATING ROOM FOR A LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMIES AND A LAPAROSCOPIC BURCH, COLPOPEXY AND POSTERIOR REPAIR. SUTURING DEVICE AND TIE DEVICE FROM LSI SOLUTIONS WERE REQUESTED FOR THE CASE. REPS SUPPLIED THE DEVICES (RD 180 SUTURING DEVICE X 2, AND TI-KNOT DEVICE X 1 PLUS MULTIPLE SUTURES AND TIES). DURING SURGERY ONE OF THE SUTURING DEVICES MALFUNCTIONED DURING THE LOADING OF THE SUTURE CAUSING THE NEEDLE TO BE EXPOSED IN THE DEVICE AND THE SUTURE TO BE STUCK). IT HAD TROUBLE SUTURING IN THE PATIENT BUT NO SUTURE LOST. UNKNOWN WHICH OF THE SUTURING DEVICES MALFUNCTIONED THERE WERE 2 DIFFERENT LOT NUMBERS(822441 AND 821682). THE TI-KNOT DEVICE ALSO HAD DIFFICULTY LOADING AND DISPENSING THE TIE-KNOT. IT WOULD JAM IN THE DEVICE PREVENTING LOADING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964569 RD180 SUTURING DEVICE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAT LSI SOLUTIONS, INC. 822441
    1964570 TI-KNOT DEVICE SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAT LSI SOLUTIONS, INC. 821682

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention