BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH NON-BLADED OBTURATOR, NON-HANDLED W/HOUSING

    MDR report key: 290170 · Received August 15, 2000

    Report

    Report Number
    1527736-2000-03787
    Event Type
    Injury
    Date Received
    August 15, 2000
    Date of Event
    July 28, 2000
    Report Date
    July 31, 2000
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED DURING THE PROCEDURE, PNUEMOPERITONEUM COULD NOT BE MAINTAINED. THE SOURCE OF THE LEAKING PNUEMO COULD NOT BE FOUND. THE PT WAS OPENED IN ORDER TO COMPLETE THE PROCEDURE. 07/31/2000 SURGEON IS OUT OF THE COUNTRY AND WILL BE BACK IN TOWN 08/10/2000. 08/01/2000 RECEIVED MESSAGE WITH ADD'L INFO. PERSON HAS BEEN ABLE TO SPEAK WITH THE PHYSICIAN ASSISTANT AND THE SCRUB TECH. A RESPOSABLE TROCAR WAS USED AT THE UMBILICIS AND THE INSUFFLATION WOULD NOT HOLD. PERSON THEN INSERTED AN 11MM DILATING TIP REPOSABLE TROCAR AT THE SUBXYPHOID. PERSON THEN WANTED TO INSERT THE 5MM LATERAL PORTS. THE STAFF PROVIDED PERSON AN OPTIVIEW NBO TROCAR AND PERSON HAD NEVER UTILIZED ONE OF THESE TROCARS. THE STAFF BELIEVED THESE WERE THE ONLY TROCARS REMAINING ON THE SHELVES. PERSON WAS UNABLE TO INSERT THIS TROCAR FULLY DUE TO TENTING OF THE ABDOMINAL WALL. THEY VERY DILIGENTLY LOOKED FOR THE SOURCE OF LEAKAGE. THE TROCAR SEALS WERE CHECKED, POURED WATER ON THE ABDOMEN AROUND THE PORTS, CHECKED THE CARBON DIOXIDE MACHINE, DISCONNECTED THE CARBON DIOXIDE GAS AND PUT IT INTO WATER AND WERE GETTING BUBBLES. THEY WERE UNABLE TO LOCATE ANY SOURCE OF LEAKAGE AND THEREFORE THE PT WAS CONVERTED TO OPEN. THE DISPOSABLE TROCARS ARE BEING RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH NON-BLADED OBTURATOR, NON-HANDLED W/HOUSING TROCAR STABILITY SLEEVES GCJ ETHICON ENDO-SURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention