BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 20301836 · Received September 25, 2024

    Report

    Report Number
    1219930-2024-04485
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    July 13, 2024
    Report Date
    September 25, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B. OZVEREN, NEJDET KARSIYAKALI, MAHIR BULENT OZGEN, LEVENT TURKERI WORLD JOURNAL OF UROLOGY (2024) 42:493 HTTPS://DOI.ORG/10.1007/S00345-024-05177-W PUBLISHED ONLINE: 22 AUGUST 2024 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, RANDOMIZED CASE-CONTROL STUDY EXAMINED THE RELATIONSHIP BETWEEN INTRAOPERATIVE VESICOURETHRAL ANASTOMOSIS EXTRAVASATION CONTROL (VUAEC) BY MEANS OF A STANDARD BLADDER FILLING METHOD IN PREDICTING VESICOURETHRAL ANASTOMOSIS (VUA) HEALING AND EARLY POST-OPERATIVE OUTCOMES IN PATIENTS WHO UNDERWENT ROBOT-ASSISTED RADICAL PROSTATECTOMY BETWEEN (B)(6) 2020 AND (B)(6) 2023. IT WAS NOTED THAT THE VUA WAS CREATED USING A BIDIRECTIONAL 3-0 V LOC SUTURE. THERE WERE 100 PATIENTS INCLUDED IN THE STUDY AND COMPLICATIONS INCLUDED LEAKAGE AT THE ANASTOMOTIC SITE, TREATED WITH PROLONGED CATHETER INSERTION. ADDITIONALLY, ONE PATIENT WITH A PROLONGED LEAK WAS TREATED WITH TRANS PERINEAL INJECTION OF FIBRIN SEALANT INTO THE ANASTOMOTIC GAP VIA A TRANSRECTAL ULTRASONOGRAPHIC GUIDANCE UNDER LOCAL ANESTHESIA POST-OPERATIVELY ON WEEK 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2198209 UNKNOWN VLOC PRODUCT SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM COVIDIEN LP LLC NORTH HAVEN UNKNOWN VLOC PRODUCT

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R