BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH* TROC (EXACT CODE UNKNOWN)

    MDR report key: 15580927 · Received October 11, 2022

    Report

    Report Number
    3005075853-2022-06810
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    January 1, 2021
    Report Date
    October 11, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 10/11/2022. ONLY EVENT YEAR KNOWN: 2021; CAPTURED AS CITATION DATE. 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. 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 DEVICES CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE; TITLE: SIMULTANEOUS SMALL/MEDIUM UMBILICAL HERNIA REPAIR WITH\ LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG): RESULTS OF A RETROSPECTIVE CASE-MATCHED STUDY AUTHORS: ANTONIO VITIELLO, MD, GIOVANNA BERARDI, MD, NUNZIO VELOTTI, MD, VINCENZO SCHIAVONE, MD, AND MARIO MUSELLA. CITATION: SURG LAPAROSC ENDOSC PERCUTAN TECH VOLUME 31, NUMBER 5, OCTOBER 2021. THE AIM OF THIS STUDY WAS TO ASSESS THE FEASIBILITY AND COMPARE OUTCOMES OF A SIMULTANEOUS PROCEDURE VERSUS A DELAYED INTERVENTION OF PERIUMBILICAL HERNIOPLASTY IN PATIENTS UNDERGOING LAPAROSCOPIC SLEEVE GASTRECTOMY (LSG). FROM JANUARY 1, 2010 TO DECEMBER 31, 2018, 40 PATIENTS WERE DIVIDED INTO 2 MATCHED GROUPS OF 20 SUBJECTS EACH; THE FIRST GROUP UNDERWENT LSG WITH SIMULTANEOUS PERIUMBILICAL HERNIA REPAIR; IN THE SECOND, HERNIOPLASTY WAS PERFORMED AFTER WEIGHT LOSS INDUCED BY LSG. A 10MM TROCAR WITH OPTIVIEW TECHNOLOGY (JOHNSON & JOHNSONMEDICAL NV) WAS PLACED INTO THE UMBILICUS DEFECT AFTER USING OTHER ACCESSES TO REDUCE THE HERNIA CONTENT. AN INTRAPERITONEAL MESH (DUAL-MESH; GORE MEDICAL) WAS FIXED TO COVER THE DEFECT WITH A ROUND OF ABSORBABLE TACKS (SECURESTRAP; JOHNSON & JOHNSON MEDICAL). VICRYL 2/0 SUTURES AND POLYPROPYLENE 0 AND 2/0 WERE ALSO USED FOR SUBJECTS WITH OPEN ONLAY REPAIR. ALL PATIENTS UNDERWENT ROUTINE BARIATRIC FOLLOW-UP 7 DAYS AFTER SURGERY AND AT 1, 3, 6, 12, AND 24 POSTOPERATIVE MONTHS. DELAYED PROCEDURE GROUP: (N=1) TROCAR SITE HEMATOMA, (N=1) SEROMA, (N=2) REOPERATION. SIMULTANEOUS PROCEDURE GROUP: (N=1) TROCAR SITE HEMATOMA. IN THE CASE OF MORBIDLY OBESE PATIENTS WITH SMALL/ MEDIUM PERIUMBILICAL HERNIA UNDERGOING LSG, A SIMULTANEOUS APPROACH SHOULD BE OFFERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2350812 ENDOPATH* TROC (EXACT CODE UNKNOWN) LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention