BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19000092 · Received March 28, 2024

    Report

    Report Number
    2210968-2024-03523
    Event Type
    Injury
    Date Received
    March 28, 2024
    Date of Event
    April 30, 2023
    Report Date
    March 27, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AS NO CONTACT INFORMATION HAS BEEN PROVIDED, NO FOLLOW UP CAN OR WILL BE PERFORMED AT THIS TIME. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: NOT AVAILABLE.

    Description of Event or Problem · 0

    TITLE: LAPAROSCOPIC BILATERAL URETERO-ILEAL RE-IMPLANTATION AFTER OPEN RADICAL CYSTECTOMY: STEP BY STEP. AN OPEN RC (ORC) WITH BRICKER UE ANASTOMOSIS IN ILEAL CONDUIT (IC) COMPLICATED WITH BILATERAL STRICTURE AFTER 2 MONTHS (M). PATIENT PRESENTED RECURRENT UTI AND KI, SO, BILATERAL PERCUTANEOUS NEPHROSTOMIES (PN) WERE PLACED. ENDOSCOPIC BALLOON DILATION WAS ATTEMPTED, BUT IMPOSSIBLE ON THE LEFT. THUS, WE PERFORMED A LAPAROSCOPIC (LAP) 5-PORT BILATERAL UE RE-IMPLANTATION DUE TO URETERO-ILEAL STENOSIS, 6.5M AFTER ORC. PATIENT HAD SOME UTI, BUT REMAINS STENTS-FREE 9M AFTER. AFTER MAXIMUM FIBROSIS EXCISION AND URETERAL SPATULATION, WE PERFORMED AN UE BRICKER RE-IMPLANTATION OVER 7CH MONO J STENTS, USING 4-0 VICRYL IN 8 SIMPLE INTERRUPTED SUTURES, BILATERALLY. REPORTED COMPLICATION INCLUDES URINARY TRACT INFECTION (N=1). IN CONCLUSION, LAPAROSCOPY ALLOWS DIRECT VISUALIZATION OF KNOWN UE ANASTOMOSIS ISSUES THAT CONTRIBUTE TO STRICTURES: URETERAL SKELETONIZATION WITH BLOOD SUPPLY COMPROMISE LEADING TO ISCHEMIA; NOT TENSION-FREE AND WATER-TIGHT ANASTOMOSIS, FACILITATING URINE LEAK; TENSION AND ANGLED PATHWAY OF LEFT URETER UNDER THE SIGMOID MESOCOLON. IN REIMPLANTATION SURGERY, CORRECTING THESE PROBLEMS IS CHALLENGING, BUT ESSENTIAL FOR SUCCESS. CAREFUL DISSECTION, USING TRACTION AND COUNTERTRACTION, ANATOMICAL PLANES AND STRUCTURES CORRECT IDENTIFICATION AND PRESERVATION IS MANDATORY. AFTER MAXIMUM POSSIBLE EXCISION OF FIBROSIS, SUTURE WITH MUCOSA APPOSITION RATHER THAN STRANGULATION IS REQUIRED FOR A QUALITY UE ANASTOMOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494821 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other