BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRESSIVE MEDICAL INC. TROCAR CLOSURE SUTURE GRASPER

    MDR report key: 7757041 · Received August 6, 2018

    Report

    Report Number
    MW5078889
    Event Type
    Malfunction
    Date Received
    August 6, 2018
    Date of Event
    July 24, 2018
    Report Date
    August 2, 2018
    Manufacturer
    PROGRESSIVE MEDICAL INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DR STATES THAT THE PMI TROCAR CLOSURE SUTURE GRASPER MALFUNCTIONED DURING THIS PROCEDURE AND HAS BEEN MALFUNCTIONING FREQUENTLY DURING PREVIOUS PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596324 PROGRESSIVE MEDICAL INC. TROCAR CLOSURE SUTURE GRASPER LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ PROGRESSIVE MEDICAL INC. PMITCSG 004171112

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR