BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 20567903 · Received October 30, 2024

    Report

    Report Number
    1717344-2024-02023
    Event Type
    Injury
    Date Received
    October 30, 2024
    Date of Event
    June 30, 2024
    Report Date
    October 30, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU (LOT#UNKNOWN); UNKNOWN EGIA SU, UNKNOWN ENDO GIA SULU (LOT#UNKNOWN); UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#UNKNOWN) REFERENCES: DONG WANG, SURGICAL ENDOSCOPY (2024) THE LEARNING CURVE OF LAPAROSCOPIC SPLENECTOMY AND ESOPHAGOGASTRIC DEVASCULARIZATION FOR PORTAL HYPERTENSION WITH 10-YEAR FOLLOW-UP; 38:5228¿5238 HTTPS://DOI.ORG/10.1007/S00464-024-11017-0. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY ASSESSED THE LEARNING CURVE OF LAPAROSCOPIC SPLENECTOMY AND ESOPHAGOGASTRIC DEVASCULARIZATION (LSED) FOR TREATMENT OF PORTAL HYPERTENSION BETWEEN 2005 AND 2020. THERE WERE FIVE HUNDRED AND NINETY-FOUR (594) PATIENTS WITH LIVER CIRRHOSIS WERE RETROSPECTIVELY ANALYZE. TWO HUNDRED THIRTY SIX (236) PATIENTS WHO UNDERWENT OPEN SURGERY, AND THREE HUNDRED FIFTY EIGHT (358) UNDERWENT LSED. IN THE LSED GROUP, LIGASURE, COMPANY¿S STAPLER OR OTHER DEVICES WERE UTILIZED FOR VESSEL DISRUPTION. COMPANY¿S STAPLER WAS USED TO TRANSECT THE SPLENIC HILUM AND THE ROOT OF THE LEFT GASTRIC VEIN. IN TRADITIONAL OPEN SURGERY, SURGICAL TECHNIQUES INCLUDING CLAMP, TRANSECTION, LIGATION, AND SUTURE WERE PERFORMED IN A CONVENTIONAL WAY. COMPLICATIONS IN THE LSED GROUP INCLUDED BLEEDING. CONVERSION TO OPEN SURGERY WAS REPORTED DUE TO INTRAOPERATIVE BLEEDING. ENDOSCOPIC TREATMENT AND ADDITIONAL SURGERY WERE REQUIRED TO TREAT POSTOPERATIVE BLEEDING. TWO PATIENTS NEEDED ICU MANAGEMENT DUE TO HYPOTENSION AND SHOCK. TRANSFUSIONS WERE ALSO REPORTED. BLEEDING WAS IDENTIFIED IN THE RETROPERITONEUM POSTERIOR TO THE SPLEEN OR AT THE ROOT OF THE LEFT GASTR IC VEIN. BLEEDING IS INHERENT TO THE PROCEDURE DUE TO PORTAL HYPERTENSION, MASSIVE SPLENOMEGALY AND GASTROESOPHAGEAL VARICOSE VEINS. DUE TO COMPROMISED LIVER FUNCTION AND UNRESTORED PLATELET FUNCTION AND QUANTITY, PATIENTS WITH PHT ARE MORE SUSCEPTIBLE TO POSTOPERATIVE BLEEDING THAN OTHER PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042235 UNKNOWN LIGASURE INSTRUMENT Electrosurgical, cutting & coagulation & accessories GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention| H SEE H11