BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)

    MDR report key: 9384758 · Received November 27, 2019

    Report

    Report Number
    3005075853-2019-23837
    Event Type
    Injury
    Date Received
    November 27, 2019
    Date of Event
    January 1, 2018
    Report Date
    October 31, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K051036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2018. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    TITLE: LAPAROSCOPIC GASTRIC BYPASS WITH FUNDECTOMY AND GASTRIC REMNANT EXPLORATION (LRYGBFSE): RESULTS AT 5-YEAR FOLLOW-UP. AUTHOR(S): GIOVANNI LESTI, ALBERTO AIOLFI, ENRICO MOZZI, FABRIZIO ALTORIO, EZIO LATTUADA, FRANCESCO LESTI, GIANLUCA BONITTA, MARCO ANTONIO ZAPPA. CITATION: OBESITY SURGERY (2018) 28:2626¿2633; DOI: HTTPS://DOI.ORG/10.1007/S11695-018-3220-1. THE AIMED OF THIS OBSERVATIONAL PROSPECTIVE STUDY WAS TO ANALYZE THE MEDIUM-TERM OUTCOMES AND SAFETY OF LAPAROSCOPIC GASTRIC BYPASS WITH FUNDECTOMY AND EXPLORATION OF THE GASTRIC REMNANT (LRYGBFSE). FROM JANUARY 2008 TO DECEMBER 2015, 653 CONSECUTIVE PATIENTS UNDERWENT THE LAPAROSCOPIC GASTRIC BYPASS WITH FUNDECTOMY. 12-MM TROCAR (ENDOPATH XCEL, ETHICON) WAS INSERTED 2 CM BELOW THE SUBCOSTAL LEFT ARCH SLIGHTLY TO THE LEFT OF THE MAMMILLARY LINE. THE GASTROCOLIC LIGAMENT WAS OPENED WHERE THE RIGHT GASTROEPIPLOIC VEIN MEETS THE LEFT GASTROEPIPLOIC VEIN WITH HARMONIC ACE (ETHICON). REPORTED COMPLICATIONS FOR HARMONIC ACE INCLUDED GASTRIC ANASTOMOSIS BLEEDING (N=1) WHICH WAS SUCCESSFULLY MANAGED WITH ENDOSCOPIC CLIPPING; INTRA-ABDOMINAL BLEEDING (N=1) WHICH AN EMERGENT LAPAROTOMY WAS PERFORMED. REPORTED COMPLICATION FOR ENDOPATH XCEL TROCAR INCLUDED POST INCISIONAL TROCAR SITE HERNIA (N=2) WHICH REQUIRED A LAPAROSCOPIC REVISION. IN CONCLUSION, THE LRYGBFSE SEEMS SAFE AND EFFECTIVE WITH DURABLE RESULTS AT 5-YEAR FOLLOW-UP. ENDOSCOPIC EXPLORATION OF THE GASTRIC REMNANT IS AN ADDITIONAL VALUABLE TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181172 ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1