BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 10537735 · Received September 15, 2020

    Report

    Report Number
    3005075853-2020-04695
    Event Type
    Injury
    Date Received
    September 15, 2020
    Report Date
    August 20, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/17/2020. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: I IMAGINE IT WILL BE DUE TO SOME CASE OF DEATH REFLECTED IN IT, ALTHOUGH AS FAR AS I KNOW THE STUDY DOES NOT RELATE THE RESULTS TO THE DEVICES, BUT RATHER TO THE SURGICAL TECHNIQUE. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2019. BATCH # UNK. 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. WHAT WAS THE CAUSE OF DEATH AND IS IT RELATED TO THE USE OF THE ULTRASOUND SCALPEL? 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 · 1

    TITLE: TRANSANAL ENDOSCOPIC MICROSURGERY IN VERY LARGE AND ULTRA LARGE RECTAL NEOPLASIA. AUTHORS: X. SERRA-ARACIL; R. FLORES-CLOTET; L. MORA-LOPEZ; A. PALLISERA-LLOVERAS; S. SERRA-PLA; S. NAVARRO-SOTO. CITATION: TECHNIQUES IN COLOPROCTOLOGY (2019) 23:869¿876; DOI: HTTPS://DOI.ORG/10.1007/S10151-019-02071-1. THE AIM OF THIS OBSERVATIONAL STUDY WAS TO EVALUATE THE FEASIBILITY OF TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) IN RECTAL NEOPLASIA LARGER THAN 5 CM [COMPARING LESIONS < 5 CM, VERY LARGE(5¿7.9 CM), AND ULTRA LARGE LESIONS (= 8 CM)], FROM THE POINT OF VIEW OF PREOPERATIVE EVALUATION, SURGICAL DIFFICULTY, POSTOPERATIVE COMPLICATIONS, PERCENTAGE OF ADENOCARCINOMA IN THE DEFINITIVE HISTOLOGY, RECURRENCE, AND STENOSIS DURING FOLLOW-UP. BETWEEN JUNE 2004 AND SEPTEMBER 2018, A TOTAL OF 507 PATIENTS (MALE=308, FEMALE=199; MEDIAN AGE=70 YEARS) WERE INCLUDED IN THE STUDY. ALL PATIENTS UNDERWENT A FULL-THICKNESS EXCISION OF THE RECTAL WALL USING AN ULTRASOUND SCALPEL (ULTRACISION, ETHICON). REPORTED COMPLICATIONS INCLUDED PERITONEAL PERFORATION (N=36) WHICH THE PATIENTS UNDERWENT TRANSANAL REPAIR; RECURRENCE (N=32) WHICH 12 PATIENTS UNDERWENT RE-TEM, RESCUE RADICAL SURGERY WAS NEEDED IN 18 PATIENTS; RESECTION SPECIMEN PRESENTED INVOLVED MARGINS (N=51); TOTAL RECTAL STENOSIS (N=16) AND PARTIAL STENOSIS (N=8) IN WHICH DILATATION OF THE STENOSIS WAS REQUIRED IN 8 CASES AND TREATMENT OF THE REMAINING 16 PATIENTS WAS NOT REPORTED. IN CONCLUSION, TEM IN THESE LARGE TUMORS IS ASSOCIATED WITH HIGHER RATES OF MORBIDITY, PERITONEAL PERFORATION, FREE MARGINS AND STENOSIS. ALTHOUGH THESE TUMORS DO NOT REQUIRE TOTAL MESORECTAL EXCISION AND ARE ELIGIBLE FOR TEM, THE SURGERY MUST BE CARRIED OUT BY EXPERIENCED SURGEONS..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002261 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATOR AND HANDPIECE.