BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH OPTIVIEW SURGICAL OPTICAL OBTURATOR & SLEEVE

    MDR report key: 299162 · Received October 3, 2000

    Report

    Report Number
    1527736-2000-04806
    Event Type
    Malfunction
    Date Received
    October 3, 2000
    Date of Event
    July 19, 1999
    Report Date
    October 2, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE (1) 350 L WAS USED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY PROCEDURE. IT WAS REPORTED THAT UPON INSERTING THE TROCAR THE CLEAR TIP OF THE NBO HAD FALLEN OFF. THE BROKEN PIECE WAS RETRIEVED AND THE CASE WAS CONTINUED WITH ANOTHER INSTRUMENT. THE BROKEN PIECE IS INCLUDED IN THE BAG WITH THE RETURNED INSTRUMENT. INCLUDED ARE BOTH TYVEKS FROM THE 350 L DEVICES IT WAS UNKNWON WHICH ONE HAD THE TIP TO BREAK OFF. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH OPTIVIEW SURGICAL OPTICAL OBTURATOR & SLEEVE TRISTAR II GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other