BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE RETRIEVAL BAG 100, 10MM INTRODUCER (5/CS)

    MDR report key: 6114784 · Received November 18, 2016

    Report

    Report Number
    1320894-2016-00145
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 4, 2016
    Report Date
    November 1, 2016
    Manufacturer
    ANCHOR PRODUCTS COMPANY, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K091930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS REPORTED, "ON (B)(6) 2016, DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE TISSUE RETRIEVAL BAG 100, 10 MM BAG TORE DURING THE REMOVAL OF THE SPECIMEN." THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ANY ALTERNATE DEVICE NEEDED AND THERE WAS A MINIMAL DELAY OF 2 MINUTES. THERE HAS BEEN NO PATIENT OR USER INJURY WITH THIS REPORTED INCIDENT. THIS REPORT IS FILED ON THE BASIS OF POTENTIAL INJURY WITH RECURRENCE. THE COMPLAINT SAMPLE WAS DISPOSED OF BY THE USER FACILITY. THE LEGAL MANUFACTURER, ANCHOR PRODUCTS COMPANY, INC., IS RESPONSIBLE FOR THE INVESTIGATION AND REGULATORY REPORTING PER AGREEMENT WITH CONMED CORPORATION. PLEASE SEE REPORT NUMBER 1416891-2016-00009 FILED BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764587 TISSUE RETRIEVAL BAG 100, 10MM INTRODUCER (5/CS) SPECIMEN BAG GCJ ANCHOR PRODUCTS COMPANY, INC. N/A 67A6T

    Patients

    Seq Age Sex Outcome Treatment
    1