BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V-LOC 180

    MDR report key: 11805430 · Received May 11, 2021

    Report

    Report Number
    11805430
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    April 7, 2021
    Report Date
    April 29, 2021
    Manufacturer
    COVIDIEN LP
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    NEEDLE, FROM COVIDIEN LP V-LOC 180 BARBED POLYESTER SUTURE, BROKE WHILE IN USE INSIDE THE PATIENT DURING A LAPAROSCOPIC PROCEDURE. THE BROKEN NEEDLE WAS RETRIEVED.

    Description of Event or Problem · 1

    NEEDLE, FROM COVIDIEN LP V-LOC 180 BARBED POLYESTER SUTURE, BROKE WHILE IN USE INSIDE THE PATIENT DURING A LAPAROSCOPIC PROCEDURE. THE BROKEN NEEDLE WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702549 V-LOC 180 SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID GAM COVIDIEN LP VLOCA008L N0J1023Y

    Patients

    Seq Age Sex Outcome Treatment
    1 15330 DA