BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 160239 · Received March 30, 1998

    Report

    Report Number
    1527736-1998-00933
    Event Type
    Malfunction
    Date Received
    March 30, 1998
    Date of Event
    February 23, 1998
    Report Date
    February 27, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.50074. EES #.981504/J. D5,6; H4: INFORMATION NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN UNK PROCEDURE THE GASKET FROM A 511S TROCAR FELL INTO THE PT'S ABDOMEN. THIS GASKET WAS RETRIEVED. AN ADD'L TROCAR WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQEUNCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH DISPOSABLE SURGICAL TROCAR TROCAR GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other