BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9472916 · Received December 16, 2019

    Report

    Report Number
    2210968-2019-90870
    Event Type
    Injury
    Date Received
    December 16, 2019
    Report Date
    November 27, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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: SURG ENDOSC (2013) 27:3009¿3015; DOI 10.1007/S00464-013-2837-3. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A JOURNAL ARTICLE"TITLE: LAPAROENDOSCOPIC SINGLE-SITE COMMON BILE DUCT EXPLORATION USING THE MANUAL MANIPULATOR." AUTHORS: KAZUNORI SHIBAO; AIICHIRO HIGURE; KOJI YAMAGUCHI. CITATION: SURG ENDOSC (2013) 27:3009¿3015; DOI 10.1007/S00464-013-2837-3. THIS RETROSPECTIVELY STUDY DISCUSSED ABOUT LAPAROENDOSCOPIC-SING-SITE (LESS) SURGERY TO MANAGE COMMON BILE DUCT (CBD) STONES BY LAPAROSCOPIC CHOLEDOCHOTOMY USING A FLEXIBLE MANUAL MANIPULATOR. FROM AUGUST 14, 2009 TO JULY 16, 2011, 13 PATIENTS (MALE=7, FEMALE=6; MEAN AGE=80 ± 2.5 YEARS, RANGE=56 ¿ 87 YEARS) UNDERWENT LESS CBD EXPLORATION. DURING THE PROCEDURE, THE LOCATION OF THE CBD WAS CONFIRMED AND CYSTIC DUCT WAS DISSECTED CLOSE TO THE GALLBLADDER USING HARMONIC ACE (ETHICON) AND CLIPPED AFTER IDENTIFICATION TO PREVENT STONE MIGRATION DURING SURGERY. EITHER INTERRUPTED OR CONTINUOUS 3-0 VICRYL SUTURES (ETHICON) WAS USED TO CLOSE CHOLEDOCHOTOMY. REPORTED COMPLICATION INCLUDED MINOR BILE LEAKAGE [HARMONIC ACE (N=1)] WHICH WAS EASILY RESOLVED WITH CONSERVATIVE TREATMENT; WOUND INFECTIONS [3-0 VICRYL SUTURE (N=2)] WHICH WERE DRAINED WITHOUT ANESTHESIA. IN CONCLUSION, LESS SURGERY WAS SUCCESSFULLY APPLIED TO CBD EXPLORATION AS AN AVAILABLE ALTERNATIVE TO CONVENTIONAL LAPAROSCOPIC SURGERY. THIS METHOD IS TECHNICALLY FEASIBLE AND PRODUCES SUPERIOR COSMETIC RESULTS. THE MANUAL MANIPULATOR MAY THEREFORE HAVE SEVERAL ADVANTAGES FOR PERFORMING LESS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269900 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention