BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 23497405 · Received November 7, 2025

    Report

    Report Number
    1219930-2025-05147
    Event Type
    Injury
    Date Received
    November 7, 2025
    Date of Event
    August 20, 2025
    Report Date
    November 18, 2025
    Manufacturer
    COVIDIEN SURGICAL
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: H6 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.

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: UNKNOWN VLOC PRODUCT, (LOT# UNKNOWN) 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 LITERATURE SOURCE OF STUDY PERFORMED BETWEEN DECEMBER 2020 AND DECEMBER 2024, A BARBED SUTURE WAS USED TO LIGATE THE DORSAL VENOUS COMPLEX AND TO PERFORM THE VESICOURETHRAL ANASTOMOSIS AND CLOSURE. THE VESICOURETHRAL ANASTOMOSIS BEGAN POSTERIORLY USING THE FIRST BARBED SUTURE. A SECOND BARBED SUTURE WAS USED TO COMPLETE THE RIGHT SIDE AND BOTH SUTURES ARE TIED TOGETHER AT THE 12 O¿CLOCK POSITION TO ENSURE A WATERTIGHT CLOSURE. THERE WERE 248 PATIENTS IN THE STUDY AND POSTOPERATIVE COMPLICATIONS INCLUDED: HEMATURIA REQUIRING CATHETER FLUSHING AND URINE LEAKS WITH TREATMENT NOT REPORTED. OTHER COMPLICATIONS NOT RELATED TO THE DEVICE INCLUDED: ACUTE URINARY RETENTION, SEVERE BLADDER SPASMS, URINARY TRACT INFECTIONS, ILEUS, WOUND INFECTIONS, ATRIAL FIBRILLATION, LYMPHOCELES, AND DEEP VEIN THROMBOSIS. READMISSIONS WERE ALSO REPORTED. EXPLORING THE PROMISE OF ROBOT-ASSISTED SINGLE-PORT TRANSVESICAL RADICALPROSTATECTOMY: INSIGHTS FROM INTERMEDIATE-TERM FOLLOW-UP: JIHAD KAOUK, 2025, UROLOGIC ONCOLOGY: SEMINARS AND ORIGINAL INVESTIGATIONS 000 (2025) 1-8, HTTPS://DOI.ORG/10.1016/J.UROLONC.2025.08.015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171187 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN SURGICAL UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Required Intervention SEE H11