BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)

    MDR report key: 9660281 · Received February 3, 2020

    Report

    Report Number
    3005075853-2020-00698
    Event Type
    Injury
    Date Received
    February 3, 2020
    Report Date
    January 7, 2020
    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). BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: TRANSANAL ENDOSCOPIC MICROSURGERY: LONG-TERM EXPERIENCE, INDICATION EXPANSION, AND TECHNICAL IMPROVEMENTS. AUTHORS: DANIEL LE´ONARD ¿ JEAN-FRANC¸OIS COLIN ¿ CHRISTOPHE REMUE ¿ JACQUES JAMART ¿ ALEX KARTHEUSER. CITATION: SURG ENDOSC; DOI 10.1007/S00464-011-1869-9. THE AIMED OF THIS PROSPECTIVELY STUDY WAS TO REVIEW THE AUTHORS¿ 16-YEAR EXPERIENCE WITH TRANSANAL ENDOSCOPIC MICROSURGERY (TEM). BETWEEN NOVEMBER 1991 AND AUGUST 2008, 123 PATIENTS (FEMALE=51, MALE=72; MEAN AGE=68 YEARS, AGE RANGE=21 ¿ 91 YEARS) UNDERWENT TEM PROCEDURE WITH DIFFERENT INDICATIONS. OF THESE 123 PATIENTS, 91 PATIENTS UNDERWENT SURGERY FOR 105 ADENOMAS. HARMONIC SCALPEL (ETHICON) WAS USED IN 10 FULL-THICKNESS RESECTIONS; FOR ADENOCARCINOMAS, 9 PATIENTS UNDERWENT SURGERY IN WHICH SHARP MONOPOLAR ELECTROCAUTERY WAS USED FOR THE RESECTION IN SIX OF THE NINE PROCEDURES, WHEREAS HARMONIC SCALPEL (ETHICON) DISSECTION WAS APPLIED IN THE THREE REMAINING PROCEDURES. FOR RECTAL STENOSIS, 3 PATIENTS WERE TREATED USING A CLASSICAL STRICTUREPLASTY WHICH WAS PERFORMED BY MEANS OF A MECHANICAL STAPLER (ENDOGIA; ETHICON). REPORTED COMPLICATIONS FOR ADENOMA GROUP INCLUDED INTRAOPERATIVE COMPLICATIONS (N=2) IN WHICH ONE PATIENT UNDERWENT IMMEDIATE CONVERSION TO AN OPEN ANTERIOR RESECTION AND THE OTHER PATIENT WAS SUCCESSFULLY MANAGED MEDICALLY; REPORTED COMPLICATIONS FOR ADENOCARCINOMA GROUP INCLUDED PERITONITIS DUE TO A PERFORATION 6 DAYS AFTER SURGERY (N=1) WHICH REQUIRED A HARTMANN¿S PROCEDURE; REPORTED COMPLICATIONS FOR RECTAL STENOSIS GROUP INCLUDED PERFORATION (N=?) OCCURRED DURING STAPLED STRICTUREPLASTY OF A TIGHT STENOTIC ILEORECTAL ANASTOMOSIS LOCATED AT LEAST 20 CM FROM THE ANAL VERGE. THE PROCEDURE WAS CONVERTED TO AN OPEN REDO OF THE ILEORECTAL ANASTOMOSIS. IN CONCLUSION, TEM SHOWED TO BE A SAFE AND EFFECTIVE PROCEDURE FOR LOCAL EXCISION OF RECTAL LESIONS WITH A LOW RECURRENCE RATE AND MINIMAL CONSEQUENCES IN TERMS OF ANORECTAL FUNCTION. IN ADDITION, TEM PROVED TO BE FEASIBLE AND EFFECTIVE FOR PELVIC ABSCESS DRAINAGE AND RECTAL STENOSIS TREATMENT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125216 HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN) [INSTRUMENT, ULTRASONIC SURGICAL GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention