BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGIPRO II

    MDR report key: 19289220 · Received May 10, 2024

    Report

    Report Number
    9612501-2024-01177
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    March 13, 2024
    Report Date
    May 10, 2024
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAW
    UDI-DI
    10884521039223
    PMA / PMN Number
    K050947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, IN THE PROCESS OF PARENT LIVER TRANSPLANTATION, VASCULAR ANASTOMOSIS WAS REQUIRED. HOWEVER, THE VASCULAR SUTURE BROKE DURING THE USE OF THE VASCULAR SUTURE, CAUSING THE ANASTOMOSIS TO FAIL. THE SUTURE WAS REPLACED AND RE-ANASTOMOSIS WAS DONE. THE ISSUE INCREASED THE ANHEPATIC PERIOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2490762 SURGIPRO II SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLEN GAW DAVIS & GECK CARIBE LTD VP-76-X D1F1559Y 10884521039223

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Male