BEUDAMED
    FDA Adverse Event Summary report: N

    TISSUE RETRIEVAL SYSTEM

    MDR report key: 6154950 · Received December 8, 2016

    Report

    Report Number
    1416891-2016-00010
    Date Received
    December 8, 2016
    Date of Event
    November 7, 2016
    Report Date
    December 7, 2016
    Manufacturer
    ANCHOR PRODUCTS COMPANY
    Product Code
    GCJ
    PMA / PMN Number
    K091930
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TRS100SB2 IS USED TO RETRIEVE TISSUE DURING LAPAROSCOPIC SURGERIES. THE COMPLAINT SAMPLE WAS NOT RETURNED TO ANCHOR PRODUCTS. THE MANUFACTURING BATCH RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED.

    Description of Event or Problem · 1

    BAG TORE DURING REMOVAL OF SPECIMEN WHILE PERFORMING LAPAROSCOPIC CHOLECYSTECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807384 TISSUE RETRIEVAL SYSTEM TRS100SB2 GCJ ANCHOR PRODUCTS COMPANY TRS100SB2 73A6T

    Patients

    Seq Age Sex Outcome Treatment
    1