BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 21894806 · Received April 23, 2025

    Report

    Report Number
    3005075853-2025-02943
    Event Type
    Injury
    Date Received
    April 23, 2025
    Date of Event
    May 16, 2023
    Report Date
    April 23, 2025
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) DATE SENT: 4/23/2025 B3: PUBLICATION YEAR OF 2023 D4: BATCH # UNK D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: GIULIANI T, IBÁÑEZ JM, MONTALVÁ-ORÓN E, ROBLEDO AB, CHICOTE CM, SANZ AH, IBAÑEZ CB, MIZRAHI DC, CASTELLÓ IB, TORRES JFM, ANDÚJAR RL. SIMULTANEOUS PANCREAS-KIDNEY TRANSPLANTATION: WHICH GRAFT WARNS THE MOST? LANGENBECKS ARCH SURG. 2023 MAY 16;408(1):196. DOI: 10.1007/S00423-023-02876-7. PMID: 37191721. THIS STUDY AIMS TO OFER AN IN-DEPTH CHARACTERIZATION OF EARLY, MEDIUM-TERM, AND LATE COMPLICATIONS FOLLOWING SPK TO DERIVE INSIGHTS FOR POSTOPERATIVE MANAGEMENT AND FOLLOW-UP. ALSO, THIS STUDY IS AN OBSERVATIONAL RETROSPECTIVE ANALYSIS OF A PROSPECTIVELY MAINTAINED DATABASE AND IS CONSISTENT WITH THE STRENGTHENING THE REPORTING OF OBSERVATIONAL STUDIES IN EPIDEMIOLOGY (STROBE) STATEMENT. THE QUALITATIVE AND QUANTITATIVE ASSESSMENT OF COMPLICATIONS PRESENTED IN THIS STUDY INCLUDES BOTH DATA ON THE TYPE AND FREQUENCY OF ALL THE EVENTS RELATED TO EACH TYPE OF GRAFT AND THE WEIGHTS OF THEIR RELATIVE BURDENS. REPORTED COMPLICATIONS IN POSTOPERATIVE OUTCOME: SURGICAL MORBIDITY (N=?), CLAVIEN-DINDO GRADE I (N=?), CLAVIEN-DINDO GRADE II (90-DAY) (N=?), CLAVIEN-DINDO GRADE IIIA (90-DAY) (N=?), CLAVIEN-DINDO GRADE IIIB (90-DAY) (N=?), CLAVIEN-DINDO GRADE IVA (90-DAY) (N=?), CLAVIEN-DINDO GRADE IVB (90-DAY) (N=?), LATE COMPLICATIONS (>90 DAYS) (N=?), POSTOPERATIVE HEMORRHAGE (N=?), UNKNOWN EVENT (N=?), NON-SURGICAL COMPLICATIONS (N=?). IN CONCLUSION, PANCREAS GRAFT-RELATED COMPLICATIONS REPRESENT THE LARGEST PART OF THE CLINICAL BURDEN IN THE EARLY POSTOPERATIVE. TIMEFRAME BUT ARE NEGLIGIBLE AFTER 3 MONTHS. KIDNEY GRAFTS HAVE A RELEVANT IMPACT IN THE LONG TERM. THE MULTIDISCIPLINARY APPROACH TO SPK RECIPIENTS SHOULD BE DRIVEN BASED ON ALL GRAFT-SPECIFC COMPLICATIONS AND TAILORED ON A TIME-DEPENDENT BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1292247 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention