BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 62346 · Received December 18, 1996

    Report

    Report Number
    1051710-1996-90001
    Event Type
    Injury
    Date Received
    December 18, 1996
    Date of Event
    October 5, 1993
    Report Date
    December 17, 1996
    Manufacturer
    SYMBIOSIS, INC
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NOTIFICATION OF LAWSUIT WAS RECEIVED 10/16/96. THE COMPLAINT STATES THAT PT UNDERWENT A LAPAROSCOPY AND HYSTEROSCOPY AND A PUNCTURE OF THE RIGHT COMMON ILIAC ARTERY AND VEIN OCCURRED. THERE WERE TWO TROCARS (11MM AND 5MM) AND A NEEDLE INSTRUMENT USED DURING THE PROCEDURE. COMPLAINT ALLEGES DEFECTIVE TROCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK TROCAR ACCESSORY GCJ SYMBIOSIS, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention