BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH XCEL TROCAR

    MDR report key: 22412099 · Received July 7, 2025

    Report

    Report Number
    3005075853-2025-05181
    Event Type
    Injury
    Date Received
    July 7, 2025
    Date of Event
    March 29, 2019
    Report Date
    July 7, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 7/7/2025. THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF PUBLISHED SCIENTIFIC ARTICLES CAPTURED UNDER CAPA-014204.

    Additional Manufacturer Narrative · 0

    (B)(4). B3: UNKNOWN; CAPTURED AS AWARENESS DATE. DATE SENT: 7/7/2025. D4: BATCH # UNK. D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. D4: UDI: THE EXPIRATION DATE IS CURRENTLY NOT AVAILABLE. THEREFORE, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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. 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: LAPAROSCOPIC RADIOFREQUENCY ABLATION FOR TRAUMATIC SPLENIC RUPTURE. AUTHORS: YI LI, BS; LIJUAN CUI, MS; WEI ZHANG, MD; YINSHENG TIAN, BS; MIN LI, MD. CITATION: JOURNAL OF SURGICAL RESEARCH. 2013; 185: 711-716. DOI: HTTP://DX.DOI.ORG/10.1016/J.JSS.2013.06.018. LAPAROTOMY WAS FORMERLY THE ROUTINE APPROACH FOR TREATING TRAUMATIC SPLENIC RUPTURE. THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE USE OF LAPAROSCOPIC RADIOFREQUENCY ABLATION (RFA) TO TREAT TRAUMATIC SPLENIC RUPTURE. FOUR PATIENTS WITH TRAUMATIC SPLENIC RUPTURES UNDERWENT LAPAROSCOPIC RFA-ASSISTED SPLEEN-PRESERVING SURGERY BETWEEN SEPTEMBER 2011 AND APRIL 2012. DURING THE PROCEDURE, AN ANGLED SCOPE AND STANDARD LAPAROSCOPIC INSTRUMENTS WERE USED WITH AN ENDOPATH XCEL 12-MM TROCAR (ETHICON), ELECTRODE COAGULATION DEVICE, A MULTI-POLAR RFA INSTRUMENT, AND AN ABSOLOK LIGATION CLAMP (ETHICON) FOR OMENTAL VASCULAR LIGATION. REPORTED COMPLICATIONS INCLUDED PATIENT 3, A 56-YEAR-OLD MAN WITH ABDOMINAL PAIN AFTER SEVERE COUGH, HEMORRHAGIC SHOCK SYMPTOMS, AND THE COLOR DOPPLER ULTRASOUND CONFIRMED INTRA-ABDOMINAL BLEEDING AND HEMATOMA BEHIND THE SPLENIC PEDICLE IN WHICH AN EMERGENCY LAPAROTOMY AND SPLENECTOMY WAS IMMEDIATELY PERFORMED. THIS REPORT DEMONSTRATED THE FEASIBILITY OF RFA-ASSISTED LAPAROSCOPIC SPLENECTOMY FOR SELECTED PATIENTS WITH TRAUMATIC SPLENIC RUPTURE. LAPAROSCOPIC RFA-ASSISTED SPLEEN-PRESERVING SURGERY IS ANOTHER MODALITY THAT MAY BE CONSIDERED IN THE MANAGEMENT OF SPLENIC TRAUMA. THIS SMALL SAMPLE SIZE AND LIMITED CLINICAL EXPERIENCE DOES NOT JUSTIFY ITS USE ON A ROUTINE BASIS AND REQUIRES ADDITIONAL CLINICAL RESEARCH TO FULLY EVALUATE ITS EFFICACY IN CERTAIN CRITICAL TRAUMATIC SCENARIOS COMPARED WITH THAT OF TRADITIONAL OPEN SPLENECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051067 ENDOPATH XCEL TROCAR LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention