BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP OBTURATOR & HOUSING

    MDR report key: 340657 · Received June 4, 2001

    Report

    Report Number
    1527736-2001-02867
    Event Type
    Malfunction
    Date Received
    June 4, 2001
    Date of Event
    May 18, 2001
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEVICE WAS USED DURING A DIAGNOSTIC LAPAROSCOPIC PROCEDURE. THE SIDE OF SHIELD ON THE DEVICE COMPLETELY BROKE OFF INTO SUB-Q OF PT DURING INSERTION. THERE WERE NO COMPLICATIONS TO THE PT. THE SURGEON DID ACTIVATE SHIELD BY DEPRESSING ORANGE BUTTON. OPENED ANOTHER DEVICE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25848 ENDOPATH DILATING TIP OBTURATOR & HOUSING TROCAR STABILITY SLEEVES GCJ ETHICON ENDO-SURGERY, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other