BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGASURE LAPAROSCOPIC SLR/DIV

    MDR report key: 721108 · Received May 30, 2006

    Report

    Report Number
    1219930-2006-00243
    Event Type
    Injury
    Date Received
    May 30, 2006
    Date of Event
    March 30, 2006
    Report Date
    May 15, 2006
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE LS1100 HAD BEEN USED FOR DISSECTION OF THE LIGAMENTS ON THE UTERUS. A MONOPOLY HOE WAS ALSO USED FOR OPENING OF THE VAGINA VAULT. AFTER OPENING OF THE VAGINA VAULT, THE LS110 WAS USED FOR THE CIRCULAR DISSECTION OF THE CERVIX UTERI FROM THE VAGINA. DURING USE OF THE LS1100, THERE WAS NO ERROR MESSAGE AND THE SEALING AREA WAS CORRECTLY SEALED. THE DEVICE DID NOT CONTACT THE SMALL BOWEL DURING THE WHOLE OPERATION. NEXT TO THE MONOPOLY HOE, THERE WERE USED BLUNT AND SHARP FORCEPS. BY THE END OF SURGERY, NO ABNORMALITIES OR SIGNS OF INNER LESIONS WERE NOTICED. TWO DAYS AFTER SURGERY, THE PT COMPLAINED ABOUT SLIGHT ABDOMINAL TROUBLES LIKELY RELATED TO FLATULENCE. ON DAY THREE AFTER SURGERY, THE TROUBLES OF THE PT INCREASED AND THE SURGICAL SVC WAS CONSULTED. AFTER THE TROUBLES INCREASED FURTHER THE FOLLOWING DAY AND THE PT'S ABDOMEN BEGAN TO DISTEND, AN OPEN OPERATION WAS DONE AFTER A CT EXAMINATION. DURING THAT EXAMINATION, A 5MM CIRCULAR LOCAL DEFECT WITH A WHITISH EDGE WAS FOUND IN THE SMALL INTESTINE (CENTRAL ABDOMINAL AREAL. PROCEDURE: LAPAROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGASURE LAPAROSCOPIC SLR/DIV ELECTROSURGICAL DEVICE GEI NORTH HAVEN - USS * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention