BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9662795 · Received February 3, 2020

    Report

    Report Number
    3005075853-2020-00728
    Event Type
    Injury
    Date Received
    February 3, 2020
    Report Date
    January 6, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2012. BATCH # UNK. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    TITLE: UROLOGIC COMPLICATIONS OF LAPAROSCOPIC RADICAL HYSTERECTOMY AND LYMPHADENECTOMY, AUTHOR/S: JONG HA HWANG, MYONG CHEOL LIM, JAE YOUNG JOUNG, SANG-SOO SEO, SOKBOM KANG, HO KYUNG SEO, JINSOO CHUNG & SANG-YOON PARK; CITATION: INT UROGYNECOL J (2012) 23:1605¿1611, DOI 10.1007/S00192-012-1767-2. THE OBJECTIVE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE INTRA- AND POSTOPERATIVE UROLOGIC COMPLICATIONS AND MANAGEMENT IN PATIENTS WITH CERVICAL OR ENDOMETRIAL CANCER TREATED WITH LAPAROSCOPIC RADICAL HYSTERECTOMY (LRH) AND LYMPHADENECTOMY. THERE WERE 134 PATIENTS (MEAN AGE, 48.2±10.8 YEARS) WITH CERVICAL CANCER AND 12 PATIENTS (MEAN AGE, 53.2±8.4 YEARS) WITH ENDOMETRIAL CANCER WHO UNDERWENT LRHS BETWEEN AUGUST 2002 AND APRIL 2011. LRH WAS PERFORMED USING ADVANCED BIPOLAR DEVICES, SUCH AS LIGASURE®, HARMONIC SCALPEL®, AND ENSEAL®. ONE PATIENT HAD A BLADDER INJURY INTRAOPERATIVELY AND WAS SUCCESSFULLY REPAIRED UNDER LAPAROSCOPY. FOUR PATIENTS ((B)(6) Y/O) DEVELOPED URETEROVAGINAL FISTULAS. ALL FOUR PATIENTS EXPERIENCED WATERY VAGINAL DISCHARGE. TWO PATIENTS ((B)(6) Y/O) DEVELOPED VESICOVAGINAL FISTULAS. ONE PATIENT ((B)(6) Y/O) HAD A BLADDER INJURY (MEDIAL TO RIGHT URETEROVAGINAL JUNCTION) POSTOPERATIVELY AND ANOTHER PATIENT ((B)(6) Y/O) HAD A URETER INJURY (LEFT DISTAL URETER). BOTH PATIENTS HAD AN INCREASE IN THE OUTPUT FROM THE JP DRAIN. ONE PATIENT ((B)(6) Y/O) EXPERIENCED FLANK PAIN AND WAS REPORTED TO HAVE HYDRONEPHROSIS (LEFT DISTAL URETER). COMPUTED TOMOGRAPHY (CT) UROGRAPHY WAS PERFORMED IN 8 PATIENTS WHO HAD UTEROVAGINAL FISTULA (N=4), VESICOVAGINAL INJURY ((B)(6) Y/O), BLADDER INJURY, AND URETER INJURY. KIDNEY SONOGRAPHY AND PELVIC CT WAS PERFORMED IN THE PATIENT WITH FLANK PAIN. INTRAVENOUS INDIGO CARMINE LEAKAGE TESTS WERE PERFORMED IN 4 PATIENTS. THE POSTOPERATIVE BLADDER INJURY WAS CONSERVATIVELY TREATED WITH AN INDWELLING URETHRAL CATHETER FOR 2 WEEKS. OF THE 4 PATIENTS WITH URETEROVAGINAL FISTULAS, 2 PATIENTS ((B)(6) Y/O) (WITH URETEROVAGINAL FISTULAS ON THE RIGHT DISTAL URETER) WERE CONSERVATIVELY TREATED WITH CYSTOSCOPIC INSERTION OF URETERAL STENTS (DJ CATHETERS). ONE PATIENT ((B)(6) Y/O) WITH URETEROVAGINAL FISTULA ON BOTH URETERS, HAD HER URETHRAL CATHETER REMOVED ON POSTOPERATIVE DAY 82. A FOLLOW-UP ABDOMINOPELVIC CT SCAN REVEALED A URINOMA. THE URINOMA WAS REMOVED AND A RIGHT URETERONEOCYSTOSTOMY WAS THEN PERFORMED. THE REMAINING PATIENT ((B)(6) Y/O) WITH URETEROVAGINAL FISTULA ON THE DISTAL RIGHT URETER HAD PERCUTANEOUS NEPHROSTOMIES PERFORMED. ON POSTOPERATIVE DAY 27 DUE TO PERSISTENT VAGINAL LEAKAGE. THE LEAKAGE CONTINUED AND A RIGHT URETERONEOCYSTOSTOMY WAS DONE ON POSTOPERATIVE DAY 191. A URETERAL CATHETER (LEFT DJ INSERTION) WAS INSERTED IN THE PATIENT ((B)(6) Y/O) WITH FLANK PAIN AND DIAGNOSED WITH HYDRONEPHROSIS. THE FLANK PAIN PERSISTED DESPITE ANTIBIOTIC THERAPY. A FOLLOW-UP KIDNEY ULTRASONOGRAPHY WAS PERFORMED AND SHOWED RESOLUTION OF THE HYDRONEPHROSIS AND THE SYMPTOMS WERE RELIEVED. THE TWO PATIENTS WITH VESICOVAGINAL FISTULAS UNDERWENT VESICOVAGINAL FISTULA REPAIRS. OF THESE 2 PATIENTS, 1 ((B)(6) Y/O) ALSO UNDERWENT LEFT URETERONEOCYSTOSTOMY. IN CONCLUSION, THE AUTHORS REPORTED THAT IATROGENIC LOWER URINARY TRACT INJURIES DURING LAPAROSCOPIC RADICAL HYSTERECTOMY ARE RELATIVELY COMMON COMPLICATIONS. INTRAOPERATIVE PROPHYLACTIC URETERAL STENT INSERTION AND THE EARLY DETECTION OF UROLOGIC COMPLICATIONS POSTOPERATIVELY IS ADVISED FOR PATIENTS WHO UNDERGO LAPAROSCOPIC RADICAL HYSTERECTOMIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123839 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention