BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC SCALPEL CURVED SHEAR

    MDR report key: 9312962 · Received November 12, 2019

    Report

    Report Number
    3005075853-2019-23439
    Event Type
    Injury
    Date Received
    November 12, 2019
    Report Date
    October 31, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    PMA / PMN Number
    K002981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 11/12/2019. BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    TITLE : COMBINING ULTRASONIC DISSECTION AND THE STORZ OPERATION RECTOSCOPE: AN EFFECTIVE NEW APPROACH TO TRANSANAL ENDOSCOPIC MICROSURGERY. AUTHOR : M. M. LIRICI, M. DI PAOLA, C. PONZANO, C. G. S. HU¨ SCHER. CITATION: SURG ENDOSC (2003) 17: 1292¿1297, DOI: 10.1007/S00464-002-8727-8. THIS STUDY AIMED TO PRESENT PRELIMINARY DATA ON BOTH THE EFFICACY AND THE COST EFFECTIVENESS OF A MODIFIED TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) PROCEDURE COMBINING THE NEW STORZ OPERATION RECTOSCOPE AND ULTRASONIC DISSECTION TO OVERCOME THE LIMITATIONS OF THE ORIGINAL TECHNIQUE. THE MODIFIED TECHNIQUE HAS BEEN USED FOR 18 TEMS WITH THE FOLLOWING INDICATIONS: SIX ADENOMAS, FIVE CA (3 TUMORS LIMITED TO THE MUCOSA, 2 TUMORS INVOLVING THE SUBMUCOSA) IN SITU/T1 TUMORS, THREE T2 RECTAL CANCERS, TWO ANASTOMOTIC STRICTURES, ONE CARCINOID, AND ONE FAMILIAR POLYPOSIS. THE ULTRASONICALLY ACTIVATED 5-MM, CURVED-BLADE SCISSORS (LCSC5; ETHICON ENDOSURGERY) WAS USED FOR ULTRASONIC DISSECTION AND EXCISION. COMPLAINT INCLUDED BLEEDING (N=1) ON POSTOPERATIVE DAY 6. THIS BLEEDING OCCURRED IN A PATIENT IN WHOM, BESIDES A STANDARD FULL-THICKNESS RESECTION OF A VILLOUS ADENOMA, A MUCOSECTOMY WITHOUT SUTURE WAS PERFORMED FOR A SMALL ADJACENT LESION. BLEEDING FROM THE SITE OF MUCOSECTOMY WAS TREATED BY RECTAL SUTURING. THE DATA PRESENTED IN THIS STUDY SHOWED THAT THE COMBINATION OF THE NEW STORZ OPERATION RECTOSCOPE WITH ULTRASONIC DISSECTION MAY BE AN EFFECTIVE ALTERNATIVE. THE OVERALL COSTS ARE SIGNIFICANTLY LOWER THAN THOSE FOR THE PROCEDURE PERFORMED WITH THE ORIGINAL BUESS OPERATION RECTOSCOPE AND TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107776 HARMONIC SCALPEL CURVED SHEAR ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention