BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9652864 · Received January 31, 2020

    Report

    Report Number
    3005075853-2020-00640
    Event Type
    Injury
    Date Received
    January 31, 2020
    Report Date
    January 2, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 1996. 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: COMPLICATIONS OF 174 LAPAROSCOPIC HYSTERECTOMIES. AUTHOR/S: M.J.W. COOPER, G. CARIO, A. LAM, M. CARLTON, G. VAUGHAN AND P. HAMMILL CITATION: AUSR. NZ J OBSRER GWAEROL 1996: 36: I: 36. THE OBJECTIVE OF THIS STUDY FOR THE AUTHORS TO REPORT A CONSECUTIVE SERIES OF LAPAROSCOPIC HYSTERECTOMIES FROM A NUMBER OF SURGEONS USING DIFFERENT TECHNIQUES AND WORKING IN NEARBY CENTRES. A RETROSPECTIVE REVIEW OF THE CASE RECORDS OF 174 PATIENTS [MEAN AGE OF 45.4 (RANGE 17.8-68.5)YEARS] WHO UNDERWENT LAPAROSCOPIC HYSTERECTOMY BETWEEN SEPTEMBER, I992 AND APRIL, I995 WAS CONDUCTED. THE MEAN WEIGHT OF THE GROUP WAS 70.2 (50-121) KG AND MEAN PARITY 2.3 (0-4). THE HARMONIC SCALPEL (ULTRACISION, SMITHFIELD, USA) WAS USED IN 29 CASES, ENDOSCOPIC STAPLING DEVICES IN 135, BIPOLAR DIATHERMY IN 117, AND SUTURES AND TIES IN 84. THE COMPLICATIONS INCLUDED 1 ILEUS, 1 VOIDING DIFFICULTY, AND 1 VAULT GRANULATIONS. PATIENT WITH VAULT GRANULATIONS REQUIRED DIATHERMY TREATMENT. IN CONCLUSION, THE AUTHORS WOULD NOT SUGGEST THAT A LAPAROSCOPIC APPROACH IS A SUBSTITUTE FOR VAGINAL HYSTERECTOMY, BUT RATHER THAT ONE OF THE MAIN ADVANTAGES OF USING A LAPAROSCOPE IS THE ABILITY TO ENSURE HAEMOSTASIS AT THE COMPLETION OF THE CASE. THE COMPLICATION RATE FOR LH/LAVH IS NOT EXCESSIVE WHEN COMPARED WITH OPEN TECHNIQUES AND MAY BE EXPECTED TO DECREASE FURTHER AS SURGEONS ADVANCE ALONG THEIR INDIVIDUAL ¿LEARNING CURVE¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114044 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention