BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 19355595 · Received May 20, 2024

    Report

    Report Number
    1717344-2024-01178
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    December 4, 2023
    Report Date
    May 20, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#: UNKNOWN) EMRULLAH BIRGIN, SCHAIMA ABDELHADI, STEFEN SEYFRIED, ERIK RASBACH, MOHAMMAD RAHBARI, PATRICK TÉOULE, CHRISTOPH REISSFELDER, NUH N. RAHBARI. ROBOTIC OR LAPAROSCOPIC REPEAT HEPATECTOMY AFTER OPEN HEPATECTOMY: A COHORT STUDY. SURGICAL ENDOSCOPY (2024) 38. HTTPS://DOI. ORG/10.1007/S00464-023-10645-2. PAGES 1296¿1305 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. 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 COMPARED POSTOPERATIVE OUTCOMES OF PATIENTS WHO UNDERWENT REPEAT HEPATECTOMIES AF TER OPEN LIVER RESECTIONS BETWEEN APRIL 2018 AND MAY 2023. PARENCHYMAL TRANSECTION WAS PERFORMED USING BIPOLAR FORCEPS AND A CRUSH-CLAMPING TECHNIQUE IN COMBINATION WITH LIGASURE OR A COMPETITOR DEVICE. VESSELS WERE DIVIDED WITH OTHER DEVICES. TWENTY PATIENTS UNDERWENT MINIMALLY INVASIVE REPEAT HEPATECTOMY (MIRH) AND 26 UNDERWENT OPEN REPEAT HEPATECTOMY(ORH). POSTOPERATIVE COMPLICATIONS INCLUDED: BILE LEAK AND POSTHEPATIC HEMORRHAGE. GRADE A COMPLICATIONS WERE TREATED WITH DIURETICS AND BLOOD TRANSFUSIONS. ONE PATIENT UNDERWENT REOPERATION DUE TO GRADE C POSTHEPATECTOMY HEMORRHAGE. POSTHEPATECTOMY BILE LEAKAGE WAS TREATED WITH INTERVENTIONAL DRAINAGE OR SURGICAL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749928 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention| O