BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 499335 · Received December 1, 2003

    Report

    Report Number
    1219930-2003-00273
    Event Type
    Death
    Date Received
    December 1, 2003
    Date of Event
    November 1, 2003
    Report Date
    November 11, 2003
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    KNS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PROCEDURE: LAPAROSCOPIC SPLENECTOMY. REPORTEDLY, A LAPAROSCOPIC INSPECTION OF THE SPLEEN SHOWED THE TAIL OF THE PANCREAS OBSTRUCTING ACCESS TO THE HILAR VESSELS. USING A SURGICAL STAPLER MD PERFORMED A DISTAL PANCREATECTOMY TO EXPOSE THE HILUM OF THE SPLEEN. HE THEN USED THE LIGASURE TO LIGATE THE SUPERIOR AND INFERIOR POLE VESSELS OF THE SPLEEN AND A SURGICAL STAPLER TO DIVIDE THE HILAR VESSELS. THE SURGICAL FIELD WAS DRY AT THE CONCLUSION OF THE CASE AND THE IMMEDIATE POST-OP PERIOD WAS UNEVENTFUL. FOLLOWING THE SURGERY, THE PATIENT DEVELOPED PANCREATITIS WITH ELEVATED SERUM AMYLASE AND LIPASE. THE SURGEON INDICATED THAT IT WAS A RELATIVELY MILD CASE WHICH RESOLVED WITHIN A FEW DAYS ALLOWING THE PATIENT TO BE DISCHARGED FROM THE HOSPITAL. ON POST-OP DAY 6 THE PATIENT RETURNED TO THE EMERGENCY ROOM WHERE THEY COLLASED. PATIENT WAS TAKEN TO THE OR FOR AN EMERGENCY LAPAROTOMY WHICH REVEALED A SMALL SUPERIOR POLE VESSEL THAT HAD BEEN SEALED WITH LIGASURE, BLEEDING FREELY. THE PATIENT EXPIRED IN THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE LAPAROSCOPIC SLR/DIV VESSEL SEALER/DIVIDER KNS NORTH HAVEN - USS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death ENDO GIA - SIZE/LOT UNKNOWN.