BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9530434 · Received December 30, 2019

    Report

    Report Number
    3005075853-2019-24818
    Event Type
    Injury
    Date Received
    December 30, 2019
    Date of Event
    January 1, 2001
    Report Date
    December 5, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT DATE: PUBLICATION YEAR OF 2001. BATCH # UNK. 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/BATCH NUMBER HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ENTITLED: ROUTINE CYSTOSCOPY AFTER LAPAROSCOPICALLY ASSISTED HYSTERECTOMY: WHAT'S THE POINT? AUTHOR/S: ELVIS I. SEMAN, ROBERT T. O'SHEA, SIMON GORDON AND JOHN MILLER CITATION: GYNAECOLOGICAL ENDOSCOPY 2001 10, 253 ¿ 256. THIS RETROSPECTIVE OBSERVATIONAL STUDY WAS TO DEFINE THE ROLE OF ROUTINE CYSTOSCOPY FOLLOWING LAPAROSCOPICALLY ASSISTED HYSTERECTOMY IN THE EARLY DETECTION OF URETERIC INJURIES. BETWEEN JUNE 1991 TO DECEMBER 1999, 436 PATIENTS WERE EVALUATED IN THE STUDY, IN WHICH 183 WOMEN UNDERWENT LAPAROSCOPICALLY INTRAFASCIAL HYSTERECTOMY AND 253 WOMEN UNDERWENT LAPAROSCOPICALLY ASSISTED TOTAL OR SUBTOTAL INTRAFASCIAL HYSTERECTOMY, WITH OR WITHOUT BILATERAL SALPINGO-OOPHORECTOMY. HARMONIC SCALPEL (ETHICON) WAS USED IN TOTAL LAPAROSCOPIC HYSTERECTOMY (TLH). REPORTED COMPLICATION INCLUDED RIGHT URETEROVAGINAL FISTULAE WITHIN 12 DAYS OF SURGERY (N=1). IN CONCLUSION, ROUTINE CYSTOSCOPY AT INTRAFASCIAL LAPAROSCOPICALLY ASSISTED HYSTERECTOMY HAS NOT CONTRIBUTED TO THE EARLY DIAGNOSIS AND TREATMENT OF URETERIC INJURIES SUSTAINED WITH THE AUTHORS' CURRENT TECHNIQUE. THUS, CYSTOSCOPY OUGHT TO BE DONE SELECTIVELY ACCORDING TO CLINICAL INTRAOPERATIVE CONCERN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324256 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention