BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 24660847 · Received March 23, 2026

    Report

    Report Number
    3005075853-2026-02150
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 23, 2026
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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: 3/23/2026. 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. 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 DEVICE 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: 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 JANUARY 2015 AND DECEMBER 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
    720203 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H