BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 296406 · Received September 13, 2000

    Report

    Report Number
    1527736-2000-04346
    Event Type
    Malfunction
    Date Received
    September 13, 2000
    Date of Event
    August 15, 2000
    Report Date
    August 15, 2000
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) 511LD, (1) WERE USED DURING A LAP RADICAL PROSTATECTOMY PROCEDURE. IT WAS REPORTED BY THE REP THAT HE SHOWED THE SURGEON THE OPTIVIEW TROCAR. THE REP STATED THAT HE BROUGHT A SAMPLE FOR THE SURGEON TO TRY (511H) BUT HE WANTED THE THREADED CANNULA. THE SURGEON DECIDED TO OPEN A 511SD AND USED THE THREADED SLEEVE ON THE NBO. THE SURGEON GAINED ACCESS USING A VERESS NEEDLE AND THE OPTIVIEW TROCAR AND PLACED TWO MORE 10MM BLADED TROCARS. THIS WAS DONE IN TEXTBOOK FASHION. THE CASE HAD BEEN GOING FOR ABOUT FOUR HOURS AND THE POSSIBILITY OF OPENING HAD BEEN MENTIONED MANY TIMES BY THE TWO SURGEONS. THE SURGEONS NOTICED THAT THEY WERE LOSING PNEUMO PERITONEUM AND NOTICED THREE CANNULAS LEAKING. THEY WERE THE 511SD CANNULA (PRIMARY PUNCTURE, ONLY THE CAMERA HAD BEEN PLACED IN IT) AND TWO 5MM PORTS. THEY WERE EXCHANGED AND THE CASE CONTINUED FOR ABOUT AN HOUR AND A HALF. THE PT WAS THEN OPENED TO COMPLETE THE CASE, THE EXCHANGE OF TROCARS TOOK TWO MINUTES AND DID NOT CAUSE ANY NEGATIVE PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other