BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6073334 · Received November 2, 2016

    Report

    Report Number
    1320894-2016-00137
    Event Type
    Malfunction
    Date Received
    November 2, 2016
    Date of Event
    September 12, 2016
    Report Date
    April 24, 2017
    Manufacturer
    ANCHOR PRODUCTS COMPANY, INC.
    Product Code
    GCJ
    PMA / PMN Number
    K091930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT CORRECTS THREE MINOR DISCREPANCIES IN INFORMATION PROVIDED IN THE ORIGINAL MEDWATCH. THE CORRECTIONS WERE IDENTIFIED DURING AN INTERNAL RETROSPECTIVE REVIEW OF MEDWATCH REPORTS FILED FOR COMPLAINTS RECEIVED BY CONMED BETWEEN 01/01/2015 AND 02/15/2017. THIS REVIEW WAS PERFORMED IN ACCORDANCE WITH A PRE-APPROVED PROTOCOL, CONMED DOCUMENT # (B)(4), WHICH DEFINED A PROCESS FOR PERFORMING AND DOCUMENTING REVIEWS OF PREVIOUSLY SUBMITTED MEDWATCH REPORTS FOR ACCURACY AND COMPLETENESS.

    Description of Event or Problem · 1

    AS REPORTED, ON (B)(6) 2016, DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE TISSUE RETRIEVAL BAG 100, 10MM INTRODUCER'S PURPLE TUBING BROKE IN HALF. BOTH PIECES WERE RETRIEVED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITHOUT ANY ALTERNATE DEVICE NEEDED. 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. NO LOT NUMBER WAS PROVIDED BY THE COMPLAINANT. ATTEMPTS TO OBTAIN FURTHER INFORMATION FROM THE HOSPITAL WERE UNSUCCESSFUL. THE LEGAL MANUFACTURER, ANCHOR PRODUCTS COMPANY, INC., HAS PROVIDED US WITH THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. PLEASE SEE REPORT NUMBER 1416891-2016-00008 FILED BY MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725966 TISSUE RETRIEVAL BAG 100, 10MM INTRODUCER (5/CS) TISSUE RETRIEVAL SYSTEM GCJ ANCHOR PRODUCTS COMPANY, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention