BEUDAMED
    FDA Adverse Event Other Summary report: N

    ENDOPATH DILATING TIP TROCAR

    MDR report key: 207602 · Received December 18, 1998

    Report

    Report Number
    1527736-1998-04329
    Event Type
    Other
    Date Received
    December 18, 1998
    Report Date
    December 4, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC. S.A. DE C.V.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THE REP WAS TOLD BY THE CONTACT PERSON THE PT RECEIVED A POST-OP 800CC BLOOD TRANSFUSION ON WHAT IS THOUGHT TO BE THE DAY OF SURGERY. THE REP WAS TOLD THE SURGEON ATTRIBUTES THIS TO THE USE OF AN ETHICON ENDO-SURGERY, INC DILATING TIP TROCAR. NO DEVICE IS AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME. 12/08/1998 REP RESPONDED HE SPOKE TO THE SURGEON WHO STATED BLOOD WAS DRIPPING INTERNALLY FROM THE SUB-XYPHOID TROCAR SITE. PROCEDURE COMPLETED AND PT SENT HOME SAME DAY. PT WAS READMITTED WITH 600CC BLOOD LOSS, HEMATOCRIT 20. REP CANNOT CONFIRM PRODUCT. IT IS EITHER 511SD OR 512SD. REP THINKS IT IS 512SD. 12/08/1998 REP CONFIRMED PRODUCT CODE-512SD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention