BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9470631 · Received December 14, 2019

    Report

    Report Number
    3005075853-2019-24338
    Event Type
    Injury
    Date Received
    December 14, 2019
    Report Date
    November 18, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2011. 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.

    Description of Event or Problem · 1

    TITLE : EFFICIENCY AND OUTCOMES OF HARMONIC DEVICE IN TRANSANAL ENDOSCOPIC MICROSURGERY COMPARED WITH MONOPOLAR SCALPEL AUTHOR : J. A. GRACIA ¿ J. M. RAMIREZ ¿ D. CALLEJO ¿ M. ELIA ¿ S. MAESO ¿ V. AGUILELLA ¿ M. MARTINEZ, CITATION: SURG ENDOSC (2011) 25:3209¿3213; DOI 10.1007/S00464-011-1695-0. THE PURPOSE OF THIS PAPER WAS TO COMPARE THE COSTS OF PERFORMING TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) WITH HARMONIC SCALPEL AND CLASSIC MONOPOLAR SCALPEL AND TO ANALYZE COMPLICATIONS. FROM 1997 TO JAN2010, 229 PATIENTS WITH RECTAL TUMORS UNDERWENT TEM WITH EITHER HARMONIC SCALPEL (N=87) OR MONOPOLAR SCALPEL (N=142). IN HARMONIC SCALPEL GROUP, LOCAL FULL-THICKNESS EXCISION WAS PERFORMED WITH THE ULTRACISION AND IN TUMORS CLOSE TO DENTATE LINE A PARKS¿ RETRACTOR WAS USED TOO TO HELP RESECTION. COMPLICATIONS IN HARMONIC SCALPEL GROUP INCLUDED RECTAL STRICTURE (N=1), POSTOPERATIVE BLEEDING (N=7) AND RECTAL PERFORATION (N=1). HARMONIC SCALPEL PROVIDES A SAFER, EASIER, AND MORE PRECISE SURGICAL SECTION THROUGH CLEAN, BLOODLESS, AND BETTER VISUALIZED OPERATIVE FIELD. BESIDES, ULTRACISION MANEUVERABILITY ALLOWS A CLEAN DISSECTION OF THE MARGIN RESECTION WHAT DECREASES THE RECURRENCE RATE. IN OTHER WORDS, HARMONIC SCALPEL IN TRANSANAL RECTAL SURGERY IS A GOOD TECHNIQUE FOR THE MANAGEMENT OF RECTAL TUMORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265283 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention