BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9739956 · Received February 21, 2020

    Report

    Report Number
    3005075853-2020-01164
    Event Type
    Injury
    Date Received
    February 21, 2020
    Report Date
    January 23, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2003. 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: LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH EXTRAPERITONEAL MESH AUTHORS: PRADEEP K. CHOWBEY, MS, MNAMS, FIMSA, FAIS, FICS, ANIL SHARMA, MS, FICS, FRCS, RAJESH KHULLAR, MS, FICS, VANDANA SONI, MS, AND MANISH BAIJAL, DNB, MNAMS CITATION: SURGICAL LAPAROSCOPY, ENDOSCOPY & PERCUTANEOUS TECHNIQUES VOL. 13, NO. 2, PP. 101¿105. THIS STUDY DISCUSSED ABOUT THE LAPAROSCOPIC VENTRAL HERNIA REPAIR WITH EXTRAPERITONEAL MESH. BETWEEN JUNE 1998 AND JUNE 2000, 34 PATIENTS (FEMALE=24, MALE=10; MEAN AGE=52 YEARS, AGE RANGE=34-70 YEARS; MEAN BMI=27.4, BMI RANGE-23-34) UNDERWENT LAPAROSCOPIC EXTRAPERITONEAL MESH PLACEMENT FOR REPAIR OF VENTRAL HERNIA. DURING THE PROCEDURE, THE PRE-PERITONEAL SPACE WAS CREATED WITH A HARMONIC SCALPEL (ULTRACISION; ETHICON) IN 3 PATIENTS AND A COMBINATION OF SHARP AND BLUNT DISSECTION IN 31 PATIENTS. REPORTED COMPLICATIONS INCLUDED IATROGENIC PERITONEAL TEARS (N=?). IN CONCLUSION, LAPAROSCOPIC EXTRAPERITONEAL PLACEMENT OF A MESH IS FEASIBLE AND APPEARS TO BE AN ADVANCE OVER LAPAROSCOPIC INTRAPERITONEAL MESH PLACEMENT FOR INCISIONAL HERNIAS IN SELECTED PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205501 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other