BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 147540 · Received February 4, 1998

    Report

    Report Number
    1527736-1998-00263
    Event Type
    Malfunction
    Date Received
    February 4, 1998
    Date of Event
    January 2, 1998
    Report Date
    January 7, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.48420. EES #.980138-2/J/. DEVICE-B D5,6; H4: INFO NOT AVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A LAPAROSCOPIC BURCH PROCEDURE AND MOSKOWITZ WHILE USING AN EMS STAPLER IT WAS DISCOVERED TO ONLY HAVE FIVE STAPLES IN THE DEVICE. A NEW EMS STAPLER WAS PULLED TO COMPLETE THE CASE. IT WAS ALSO REPORTED THE SEALS TORE OF TWO 512SD TROCARS. THE CASE WAS COMPLETED BY USING REDUCER CAPS WITH THE SAME 512SD TROCARS. THERE WERE NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other