BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DISPOSABLE SURGICAL TROCAR

    MDR report key: 157505 · Received March 16, 1998

    Report

    Report Number
    1527736-1998-00742
    Event Type
    Malfunction
    Date Received
    March 16, 1998
    Date of Event
    February 17, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49654. EES#.981137/J. D6: DEVICE RETURNED WITH NO LOT IDENTIFICATION. ENDOPATH DISPOSABLE SURGICAL TROCAR: BASED UPON INQUIRY INFO RECEIVED, VISUAL EXAMINATION AND FUNCTIONAL TEST, THE REPORTED EVENT WAS CONFIRMED. THE OBTURATOR HANDLE WAS MEASURED AND FOUND TO BE SKEWED. THE OBTURATOR HANDLE IS WELDED DURING THE ASSEMBLY PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE 512S WAS USED DURING A LAPAROSCOPIC APPENDECTOMY. IT WAS REPORTED BY THE AFFILIATE THE SAFETY SHIELD OF THE DEVICE WOULD NOT ACTIVATE PROPERLY. THERE WAS NO CONSEQUENCE 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