BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH ETS

    MDR report key: 285316 · Received July 11, 2000

    Report

    Report Number
    1527736-2000-03069
    Event Type
    Injury
    Date Received
    July 11, 2000
    Report Date
    June 13, 2000
    Manufacturer
    ETHICON ENDO-SURGERY
    Product Code
    KOG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (2) DEVICES WERE USED DURING A LAPAROSCOPIC COLECTOMY. IT WAS REPORTED BY THE AFFILIATE THAT THE TSB45 WAS FIRED BY THE SURGEON. THE FIRST TWO FIRINGS WENT WELL. THEN THE SURGEON RELOADED THE DEVICE WITH A TR45B AND THE STAPLER WAS THEN FIRED. THE DEVICE CUT, BUT DID NOT STAPLE, BECAUSE THE CARTRIDGE WAS EMPTY. THE SURGEON HAD TO CONVERT THE OPERATION AND MAKE A COLOSTOMY. AFTER A FEW DAYS THE PT HAD A FISTULA. THE DEVICES HAVE NOT BEEN RETURNED FROM THE HOSP. 06/20/2000, ADDITIONAL INFO FROM AFFILIATE: THE SURGEON DID NOT SPECIFY HOW MANY DAYS AFTER COLOSTOMY THE PT HAD THE FISTULA. THE FISTULA WAS TREATED PUTTING THE PT UNDER TOTAL PARENTERAL NUTRITION AND SEEMED TO IMPROVE. CO HAS CONTACTED THE SALE PROMOTER AND ASKED HIM TO GO TO THE HOSP TO KNOW IF THE PT HAS LEFT THE HOSP. OBVIOUSLY THE PT SHOULD HAVE IN SOME MONTHS ANOTHER INTERVENTION FOR RESOLVING THE COLOSTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS LINEAR CUTTERS - ENDOSCOPIC KOG ETHICON ENDO-SURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention