BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 9970619 · Received April 16, 2020

    Report

    Report Number
    2210968-2020-03120
    Event Type
    Injury
    Date Received
    April 16, 2020
    Report Date
    March 23, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (VICRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (VICRYL SUTURE) USED IN THIS PROCEDURE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURGICAL INNOVATION 1¿7; 2018; DOI: HTTPS://DOI.ORG/10.1177/15533506187658. (B)(4).

    Description of Event or Problem · 1

    TITLE: THE USE OF BARBED SUTURE FOR INTRACORPOREAL MECHANICAL ANASTOMOSIS DURING A TOTALLY LAPAROSCOPIC RIGHT COLECTOMY: IS IT SAFE? A RETROSPECTIVE NONRANDOMIZED COMPARATIVE MULTICENTER STUDY THE AIM OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF THE BARBED AUTO LOCKING ABSORBABLE SUTURE FOR THE CLOSURE OF AN ANASTOMOTIC STAPLER-ACCESS ENTEROTOMY DURING A TOTALLY LAPAROSCOPIC RIGHT COLECTOMY. BETWEEN JANUARY 2010 AND APRIL 2016, 80 PATIENTS (MALE=51, FEMALE=29; MEAN AGE 72.8 ± 10.1 YEARS; MEAN BMI=30.3 ± 7.7 KG/M^2) HAD UNDERGONE TOTALLY LAPAROSCOPIC RIGHT COLECTOMY (TLRC). DURING THE PROCEDURE, THE TRANSVERSE COLON AND TERMINAL ILEUM WERE TRANSECTED BY LAPAROSCOPIC 45-MM ENDOPATH ETS ARTICULATING LINEAR CUTTERS (ETHICON) WITH BLUE AND WHITE LOAD, RESPECTIVELY. A SIDE-TO-SIDE ILEOCOLIC ANASTOMOSIS WAS MADE BY LAPAROSCOPIC 45-MM ENDOPATH ETS ARTICULATING LINEAR CUTTERS WITH A BLUE LOAD. THE MESENTERY WAS CLOSED BY ABSORBABLE STITCH VICRYL 3/0 (ETHICON) OR FIBRIN GLUE. REPORTED COMPLICATIONS INCLUDED PAIN (N=3); POST-OPERATIVE ANEMIA/BLEEDING (N=4) WHICH REQUIRED BLOOD TRANSFUSION; ILEUS (N=4); ANASTOMOTIC LEAKAGE (N=2) TREATED WITH AN ANASTOMOSIS REDO; ANASTOMOTIC BLEEDING (N=1) WHICH WAS TREATED ENDOSCOPICALLY. IN CONCLUSION, BARBED SUTURE APPEARS TO BE SAFE AND EFFICIENT FOR CLOSURE OF THE STAPLER-ACCESS ENTEROTOMY DURING TOTALLY LAPAROSCOPIC RIGHT COLECTOMY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430420 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1