BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 21381315 · Received February 13, 2025

    Report

    Report Number
    1219930-2025-00784
    Event Type
    Injury
    Date Received
    February 13, 2025
    Date of Event
    January 15, 2025
    Report Date
    February 26, 2025
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANT PRODUCT: UNKNOWN-VLOC UNKNOWN VLOC PRODUCT (LOT UNKNOWN) MAHMOUD ABDELHAKIM, SAMER MORSY, MOHAMED ABDELGHANY, ABDELHAMID FOUAD, MOHAMED ABDELWAHAB. "OUTCOMES AND EFCACY OF ROBOTIC-ASSISTED RADICAL PROSTATECTOMY USING THE CMR VERSIUS PLATFORM: A PROSPECTIVE STUDY ON 118 PATIENTS WITH 1-YEAR FOLLOW-UP". INTERNATIONAL UROLOGY AND NEPHROLOGY 2025, HTTPS://DOI.ORG/10.1007/S11255-025-04384-7. 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

    CORRECTION: H6 ADDITIONAL REVIEW OF THE EVENT AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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 REPORTED AN INSTITUTION¿S EXPERIENCE IN PERFORMING ROBOT ASSISTED RADICAL PROSTATEC TOMY (RARP) UTILIZING THE VERSIUS ROBOTIC SURGICAL SYSTEM FOR THE TREATMENT OF PROSTATE CANCER OVER A TWO-YEAR PERIOD. IT WAS NOTED THAT THE VESICOURETHRAL ANASTOMOSIS WAS PERFORMED USING TWO MONOFILAMENTS BARBED SUTURES, STARTING AT 6 O¿CLOCK TOWARDS THE 12 O¿CL OCK BILATERALLY IN A RUNNING FASHION. THERE WERE 118 PATIENTS INCLUDED IN THE STUDY AND POST-OPERATIVE COMPLICATIONS INCLUDED URETHRACUTANEOUS FISTULA ONE PATIENT (0.84%) THAT WAS REPAIRED AFTER SIX MONTHS, AND ONE PATIENT (0.84%) DEVELOPED INTRAPERITONEAL URINE LEAK AFTER CATHETER REMOVAL WHICH WAS TREATED WITH CATHETER REINSERTION AND ULTRASOUND-GUIDED DRAIN INSERTION. OUTCOMES AND EFCACY OF ROBOTIC-ASSISTED RADICAL PROSTATECTOMY USING THE CMR VERSIUS PLATFORM: A PROSPECTIVE STUDY ON 118 PATIENTS WI TH 1-YEAR FOLLOW-UP 10.1007/S11255-025-04384-7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162285 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 Required Intervention