BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 19054077 · Received April 5, 2024

    Report

    Report Number
    1717344-2024-00913
    Event Type
    Injury
    Date Received
    April 5, 2024
    Date of Event
    October 12, 2023
    Report Date
    April 5, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN LIGASUR, UNKNOWN LIGASURE INSTRUMENT (LOT#UNKNOWN) REFERENCE: GRUBNIK, V, ET.AL, 2024, TRANSABDOMINAL AND RETROPERITONEAL ADRENALECTOMY: COMPARATIVE STUDY, SURGICAL ENDOSCOPY (2024) SURGICAL END OSCOPY (2024) 38:1541¿1547, HTTPS://DOI.ORG/10.1007/S00464-023-10533-9 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 COMPARED THE EFFECTIVENESS AND SAFETY OF TRANSABDOMINAL AND RETROPERITONEOSCOPIC LAPAROSCOPIC ADRENALECTOMY IN PATIENTS WHO UNDERWENT ADRENALECTOMIES BETWEEN 2000 AND 2021. IN ALL PATIENTS, LIGASURE WAS THE MAIN DEVICE USED TO LIGATE THE ADRENAL VEIN. IF VESSEL EXCEEDED 7MM, A COMPETITOR DEVICE WAS USED. THERE WERE 472 PATIENTS IN THE STUDY AND COMPLICATIONS INCLUDED BLEEDING. CONVERSION TO OPEN WAS REQUIRED IN ONE PATIENT DUE TO BLEEDING FROM THE LEFT ADRENAL VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623851 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other| R