BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH XCEL

    MDR report key: 24769654 · Received April 2, 2026

    Report

    Report Number
    3005075853-2026-02472
    Event Type
    Injury
    Date Received
    April 2, 2026
    Date of Event
    February 9, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    UDI-DI
    10705036001164
    PMA / PMN Number
    K032676
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 4/2/2026 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. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. 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 MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KANANI F, KOZIN M, BEN AVRAHAM Y, AVITAN E, GUREVICH M, NESHER E, GRAVETZ A. LAPAROSCOPIC LIVING DONOR NEPHRECTOMY: LEARNING CURVE ANALYSIS THROUGH 1446 CASES AND OUTCOMES FROM 200 CONSECUTIVE MASTERY-PHASE PROCEDURES-HOW I DO IT. J CLIN MED. 2026 FEB 9;15(4):1363. DOI: 10.3390/JCM15041363. PMID: 41753051; PMCID: PMC12941911. THE AIM OF THIS STUDY IS TO HIGH-VOLUME SINGLE-CENTER EXPERIENCE WITH STANDARDIZED TRANSPERITONEAL LAPAROSCOPIC DONOR NEPHRECTOMY AND CUSUM-BASED LEARNING CURVE ANALYSIS. BETWEEN (B)(6) 2015 AND (B)(6) 2024, A TOTAL OF 200 CONSECUTIVE LAPAROSCOPIC LIVING DONOR NEPHRECTOMIES WERE USING ETHICON ENDOPATH, ETHICON HARMONICACE® + SHEARSORHARMONIC SYNERGY® HOOK, ETHICON LIGACLIP®, ETHICON ECHELONFLEX¿, SURGICEL® ETHICON, 0-VICRYL, 4-0 MONOCRYL AND DERMABOND® (ETHICON). REPORTED COMPLICATIONS ARE N=8; CLAVIEN¿DINDO (GRADE I) TREATMENT: NOT MENTIONED N=3; CLAVIEN¿DINDO (GRADE II) TREATMENT: NOT MENTIONED N=1; CLAVIEN¿DINDO (GRADE=III) TREATMENT: NOT MENTIONED N=2; SUPERFICIAL SSI TREATMENT: NOT MENTIONED N=1; SEROMA TREATMENT: NOT MENTIONED N=1; INTRA-ABDOMINAL COLLECTION TREATMENT: NOT MENTIONED N=3; URINARY RETENTION TREATMENT: NOT MENTIONED N=40; ORCHALGIA (TESTICULAR PAIN-1 MONTH) TREATMENT: NOT MENTIONED N=31; ORCHALGIA (TESTICULAR PAIN-1 YEAR) TREATMENT: NOT MENTIONED N=2; 30-DAY READMISSION TREATMENT: NOT MENTIONED N=3; 90-DAY READMISSION TREATMENT: NOT MENTIONED. IN CONCLUSION, THIS HIGH-VOLUME SINGLE-CENTER EXPERIENCE DEMONSTRATES RECEIVED: 9 JANUARY 2026 REVISED: 2 FEBRUARY 2026 ACCEPTED: 5 FEBRUARY 2026 PUBLISHED: 9 FEBRUARY 2026 COPYRIGHT: © 2026 BY THE AUTHORS. LICENSEE MDPI, BASEL, SWITZERLAND. THIS ARTICLE IS AN OPEN ACCESS ARTICLE DISTRIBUTED UNDER THE TERMS AND CONDITIONS OF THE CREATIVE COMMONS ATTRIBUTION (CC BY) LICENSE. FAVORABLE OUTCOMES IN LAPAROSCOPIC LIVING DONOR NEPHRECTOMY WITH CUSUM-DEFINED PROFICIENCY PHASES EXTENDING BEYOND 1000 CASES. THE OUTCOMES OBSERVED LIKELY REFLECT THE COMBINED EFFECTS OF INSTITUTIONAL VOLUME, TEAM EXPERIENCE, AND STANDARDIZED TECHNIQUE. MULTI-CENTER VALIDATION IS REQUIRED BEFORE GENERALIZING THESE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828409 ENDOPATH XCEL LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. 10705036001164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention