BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH OPTIVIEW TROCAR 5MM NONHANDLED, 75MM

    MDR report key: 299149 · Received October 3, 2000

    Report

    Report Number
    1527736-2000-04735
    Event Type
    Malfunction
    Date Received
    October 3, 2000
    Date of Event
    August 2, 2000
    Report Date
    September 25, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THAT THE SURGEON INDICATED AT THE END OF THE PROCEDURE THAT HE FELT THE "NBO HAD A SLIGHT LEAK". THERE WAS NO CONSEQUENCE TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH OPTIVIEW TROCAR 5MM NONHANDLED, 75MM TROCARS GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other