BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 9345256 · Received November 19, 2019

    Report

    Report Number
    3005075853-2019-23599
    Event Type
    Injury
    Date Received
    November 19, 2019
    Report Date
    October 31, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # UNK. DATE OF EVENT IS UNKNOWN. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REVIEW A JOURNAL ARTICLE, 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
    1137411 ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other