BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 158723 · Received March 20, 1998

    Report

    Report Number
    1527736-1998-00796
    Event Type
    Malfunction
    Date Received
    March 20, 1998
    Date of Event
    February 5, 1998
    Report Date
    February 19, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49797. EES #.981267/J. ENDOPATH DILATING TIP TROCAR: BASED ON THE INFO RECEIVED AND THE FUNCTIONALITY TESTING IT WAS CONCLUDED THAT BOTH INSTRUMENTS A & B FAILED TO ARM DUE TO A SKEWED END CAP WELD.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A DIAGNOSTIC LAPAROSCOPY TWO 355LD TROCARS WOULD NOT ARM WHEN ORANGE BUTTON WAS PRESSED. TWO NEW 355LD TROCARS WERE USED TO COMPLETE THE CASE. THERE WAS 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 K48680

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other