BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 19356180 · Received May 20, 2024

    Report

    Report Number
    1219930-2024-02211
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    February 4, 2024
    Report Date
    May 20, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE: XUE XIAO, 2024, TRANSVAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY FOR MYOMECTOMY: A MORE SUITABLE SURGICAL APPROACH FOR ENHANCED RECOVERY AFTER SURGERY: EUROPEAN JOURNAL OF OBSTETRICS & GYNECOLOGY AND REPRODUCTIVE BIOLOGY, VOLUME 295, P143-149 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 AIMED TO EXPLORE THE SAFETY AND EFFICACY OF VAGINAL NATURAL ORIFICE TRANSLUMINAL ENDOSCOPIC SURGERY (VNOTES) SURGERY FOR MYOMECTOMY BETWEEN JANUARY 2021 AND DECEMBER 2022. AFTER REMOVING THE FIBROID A ABSORBABLE SUTURE WAS USED TO CLOSE THE TUMOR CAVITY IN TWO LAYERS. AFTER CHECKING FOR NO BLEEDING OR HEMATOMA, SUTURE THE POSTERIOR FORNIX AND PERITONEAL TISSUE OF THE VAGINA WITH A ABSORBABLE BARBED SUTURES. THERE WERE 110 PATIENTS IN THE STUDY. ONE PATIENT EXPERIENCED POSTOPERATIVE BLEEDING DUE TO INCOMPLETE SUTURING OF THE POSTERIOR UTERINE SURGERY AND UNDERWENT REOPERATION TO RESOLVE THE ISSUE. THE PATIENT WAS DISCHARGED AFTER ANTIBIOTIC ANTI INFECTION TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604381 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Hospitalization| R| O