BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9472906 · Received December 16, 2019

    Report

    Report Number
    2210968-2019-90836
    Event Type
    Injury
    Date Received
    December 16, 2019
    Report Date
    November 26, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. CITATION: TECH COLOPROCTOL (2008) 12:247¿249; DOI 10.1007/S10151-008-0427-5. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: TRANSANAL RESECTION OF RECTAL NEOPLASMS USING THE HARMONIC SCALPEL". AUTHOR(S): M. RABAU. CITATION: TECH COLOPROCTOL (2008) 12:247¿249; DOI 10.1007/S10151-008-0427-5. THIS STUDY AIMED TO PRESENT THE USE OF THE HARMONIC SCALPEL ALLOWING MORE PRECISE RESECTION OF RECTAL NEOPLASMS. OVER THE LAST YEAR (FROM THE TIME OF THE PUBLICATION), 14 PATIENTS WITH BENIGN ADENOMA (N=10), T1 ADENOCARCINOMA (N=3), AND T2 ADENOCARCINOMA (N=1) UNDERWENT TRANSANAL RESECTIONS USING HARMONIC SCALPEL. IN THE PROCEDURE, SUBMUCOSAL OR FULL-THICKNESS RESECTION ALONG THE MARKED MARGIN IS PERFORMED USING THE HARMONIC SCALPEL. THE RECTAL WOUND IS CLOSED WITH INTERRUPTED 000 VICRYL SUTURES. ALL THE PROCEDURES WENT SMOOTHLY, WITH A DRY SURGICAL FIELD AND NO NEED FOR CONTROL OF BLEEDING. ONE PATIENT WAS READMITTED WITH LATE POSTOPERATIVE BLEEDING WHICH OCCURRED 1 WEEK POSTOPERATIVELY AND REQUIRED SUTURE CONTROL. HARMONIC SCALPEL INSTEAD OF ELECTROCAUTERY ALLOWS A DRYER SURGICAL FIELD WHICH FACILITATES THE COMPLETE RESECTION OF THE NEOPLASM WITH GREATER ACCURACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269520 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention