BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACKER TUBE

    MDR report key: 132581 · Received November 12, 1997

    Report

    Report Number
    2939738-1997-00033
    Event Type
    Injury
    Date Received
    November 12, 1997
    Date of Event
    July 31, 1997
    Report Date
    August 18, 1997
    Manufacturer
    ORIGIN MEDSYSTEMS, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC BLADDER NECK SUSPENSION PROCEDURE, THE DR ACCIDENTLY PLACE A TITANIUM HELIX IN THE BLADDER. THE DR REALIZED A WEEK LATER THIS HAD OCCURRED AND POST-OPERATIVELY REMOVED THE HELIX. ACCORDING TO THE INFO PROVIDED BY THE STAFF PRESENT DURING THE CASE, THE UNIT FUNCTIONED TO SPECIFICATIONS AND NO MALFUNCTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TACKER TUBE TACKER DELIVERY SYSTEM GCJ ORIGIN MEDSYSTEMS, INC. OMS-TTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R