BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LIGASURE INSTRUMENT

    MDR report key: 19818143 · Received July 24, 2024

    Report

    Report Number
    1717344-2024-01532
    Event Type
    Injury
    Date Received
    July 24, 2024
    Date of Event
    July 14, 2022
    Report Date
    July 24, 2024
    Manufacturer
    COVIDIEN MFG DC BOULDER
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PASCALE J.M. SCHAFRAT. "CLINICAL IMPLICATIONS OF CHYLE LEAKAGE FOLLOWING ESOPHAGECTOMY". DISEASES OF THE ESOPHAGUS (2023), 36, 1¿7, HTTPS://DOI.ORG/10.1093/DOTE/DOAC047. 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 PROSPECTIVE STUDY EVALUATED POSTOPERATIVE CHYLE LEAKAGE IN PATIENTS WHO UNDERWENT ESOPHAGECTOMY BETWEEN JANUARY 2017 AND DECEMBER 2020. MEDIASTINAL DISSECTION WAS DONE USING A DISSECTOR, DIATHERMIC HOOK AND LIGASURE BLUNT TIP LAPAROSCOPIC SEALER. THERE WERE 341 PATIENTS IN THE STUDY AND POSTOPERATIVE CHYLE LEAKAGE OCCURRED IN 43. SEVERITY OF THE LEAK WAS GRADE A IN 24 PATIENTS AND GRADE B IN 19 PATIENTS. CHYLE LEAKAGE WAS SUCCESSFULLY TREATED WITH A MEDIUM CHAIN TRIGLYCERIDES (MCT) DIET IN 42 OF 43 PATIENTS. ONE PATIENT WAS SUCCESSFULLY TREATED WITH TOTAL PARENTERAL NUTRITION (TPN). NONE OF THESE PATIENTS NEEDED ADDITIONAL PLEURAL DRAINAGE OR ANOTHER RE-INTERVENTION FOR CHYLE LEAKAGE DURING INITIAL ADMISSION. THE PRESENCE OF CHYLE LEAKAGE WAS ASSOCIATED WITH AN INCREASE IN HOSPITAL STAY OF 3 DAYS. IN ONLY ONE PATIENT, CHYLE LEAKAGE WAS DIAGNOSED LATER IN THE POSTOPERATIVE PERIOD AND AFTER THORACIC DRAIN REMOVAL. THIS PATIENT NEEDED PLEURAL DRAINAGE DURING READMISSION 40 DAYS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357006 UNKNOWN LIGASURE INSTRUMENT ELECTROSURGICAL, CUTTING & COAGULATION & ACCES GEI COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| R| O