BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE

    MDR report key: 304837 · Received November 14, 2000

    Report

    Report Number
    1527736-2000-05723
    Event Type
    Injury
    Date Received
    November 14, 2000
    Date of Event
    October 20, 2000
    Report Date
    October 20, 2000
    Manufacturer
    ETHICON ENDO-SURGERY - ALB
    Product Code
    LFL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT (1) LCSC5 WAS USED DURING A LAP ESOPHAGECTOMY PROCEDURE. IT WAS REPORTED BY THE REP THAT THE SHEARS LOCKED OUT RESULTING LONGER PROCEDURE WHICH CONVERTED TO OPEN. THERE WAS EXTENDED OR TIME BY ONE HR. THIS WRITER CONTACTED THE MD. THE MD STATED THE PROCEDURE WAS NOT CONVERTED TO OPEN. MD STATED THE DEVICE DID NOT WORK AND MADE THE CASE DIFFICULT. THE MD WOULD NOT PROVIDE ANY ADD'L INFO AND REFERRED THIS WRITER TO THE SALES REP. REP STATED THE MD DID CONVERT TO OPEN. RPTR STATED THE MD STATED THEY WERE GOING TO COMPLETE THE PROCEDURE LAPAROSCOPICALLY AS MUCH AS THE MD COULD AND THEN OPEN IF MD COULD NOT GO ANY FURTHER LAPAROSCOPICALLY. THE REP STATED THE MD EXPERIENCED LOCKOUT AND BLEEDING. THE SURGEON THEN CONVERTED TO OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARMONIC SCALPEL ULTRACISION LAPAROSONIC COAGULATING SHE ULTRASONIC-SURGERY DEVICES - ENDOSC LFL ETHICON ENDO-SURGERY - ALB NA N4JX1A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention