BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VICRYL RAPIDE SUTURE

    MDR report key: 9451136 · Received December 11, 2019

    Report

    Report Number
    2210968-2019-90747
    Event Type
    Injury
    Date Received
    December 11, 2019
    Report Date
    November 19, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. CITATION: EUROPEAN UROLOGY 45 (2004) 103¿109. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: LAPAROSCOPIC EXTRAPERITONEAL ADENOMECTOMY (MILLIN): PILOT STUDY ON FEASIBILITY." AUTHORS: R. VAN VELTHOVEN, A. PELTIER, M.P. LAGUNA, AND TH. PIECHAUD. CITATION: EUROPEAN UROLOGY 45 (2004) 103¿109. THE OBJECTIVE OF THIS PILOT STUDY IS TO DESCRIBE THE SURGICAL TECHNIQUE AND TO ASSESS THE FEASIBILITY OF LAPAROSCOPIC EXTRAPERITONEAL ADENOMECTOMY. PATIENTS WITH LOWER URINARY TRACT SYMPTOMS ATTRIBUTABLE TO BENIGN PROSTATIC HYPERPLASIA WERE OFFERED AN ALTERNATIVE TO AN OPEN MILLIN OPERATION BETWEEN FEBRUARY 2001 TO JANUARY 2003. EIGHTEEN MALE PATIENTS WITH MEAN AGE OF 67.83 WERE INCLUDED AND ALL UNDERWENT LAPAROSCOPIC EXTRAPERITONEAL ADENOMECTOMY. THE OPERATION WAS PERFORMED WITH PRIMARY INTRODUCTION OF 5MM AND 10 MM PORTS FOR THE LAPAROSCOPE. THE FAT COVERING THE PROSTATIC CAPSULE IS DISSECTED AND TWO CROSS SUTURES (VICRYL RAPID® 1/0) ARE PLACED EACH ON THE LATERAL SURFACE OF THE PROSTATE. WITH THE HELP OF HARMONIC HOOK SCALPEL, THE SURGICAL CAPSULAR PLANE IS DEVELOPED DISTALLY IN THE DIRECTION OF THE APEX, LATERALLY TO THE POSTERIOR PLANE AND CRANIALLY TO THE BLADDER NECK. TRIGONIZATION IS DONE BY MEANS OF TWO TO FOUR STITCHES PLACED FROM THE POSTERIOR BLADDER NECK TO THE INTERNAL POSTERIOR ASPECT OF THE PROSTATE FOSSA (VICRYL RAPID® 2/0). THE ANTERIOR PROSTATE CAPSULE IS CLOSED BY TWO RUNNING SUTURES (VICRYL RAPID®1 1/0 WITH A TRIANGULAR NEEDLE). ONE PATIENT DEVELOPED SEPSIS DUE TO PERSISTENT OBSTRUCTION. THE PATIENT DID NOT RECUPERATE SPONTANEOUS MICTURITION AND A REOPERATION (TURP) WAS PERFORMED THREE MONTHS LATER. ONE PATIENT HAD MINIMAL BLEEDING AND WAS TREATED WITH SINGLE CATHETERIZATION. TWO PATIENTS REQUIRED DELAYED CATHETERIZATION FOR HEMATURIA (SINGLE CATHETERIZATION IN ONE CASE AND 2 DAYS CATHETERIZATION IN THE OTHER CASE).ONE PATIENT HAD LOW FLOW ONE MONTH AFTER THE OPERATION AND A MINIMAL STRICTURE OF THE BULBAR URETHRA WAS DIAGNOSED A TREATED WITH A SINGLE DILATATION. IN CONCLUSION, THE AUTHORS REPORTED THAT LAPAROSCOPIC EXTRAPERITONEAL ADENOMECTOMY (MILLIN¿S PROCEDURE) IS FEASIBLE WITH A REASONABLE COMPLICATION RATE. ALTHOUGH COMPARISON WITH OPEN ADENOMECTOMY IS NOT YET AVAILABLE, THIS TECHNIQUE MIGHT HAVE POTENTIAL ADVANTAGES IN TERMS OF BLOOD LOSS AND POSTOPERATIVE CATHETER TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1247506 UNKNOWN VICRYL RAPIDE SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention