BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7856766 · Received September 7, 2018

    Report

    Report Number
    2210968-2018-75714
    Event Type
    Injury
    Date Received
    September 7, 2018
    Report Date
    August 24, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT (VICRYL SUTURE)S 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 PRODUCT(VICRYL SUTURE)S USED IN THIS PROCEDURE? CITATION: EUR SURG. 2017; 49: 266¿274. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE :" A PROPENSITY SCORE MATCHED CASE-CONTROL COMPARATIVE STUDY OF TOTALLY LAPAROSCOPIC DISTAL GASTRECTOMY AND LAPAROSCOPIC-ASSISTED DISTAL GASTRECTOMY FOR EARLY GASTRIC CANCER". AUTHOR: SUNG DON OH ¿ SUNG JIN OH ¿ BYOUNG JO SUH ¿ JIN YONG SHIN ¿ JONG KWON PARK CITATION: EUR SURG. 2017; 49: 266¿274. DOI: HTTPS://DOI.ORG/10.1007/S10353-017-0495-8. INTRACORPOREAL ANASTOMOSIS REMAINS A DIFFICULT PROCEDURE. THIS STUDY WAS DESIGNED TO CLARIFY THE ADVANTAGE OF TOTALLY LAPAROSCOPIC DISTAL GASTRECTOMY (TLDG) COMPARED WITH LAPAROSCOPIC-ASSISTED DISTAL GASTRECTOMY (LADG) REGARDING SHORT-TERM SURGICAL OUTCOMES. THE AUTHORS RETROSPECTIVELY IDENTIFIED 196 PATIENTS WHO WERE PREOPERATIVELY DIAGNOSED WITH EARLY GASTRIC CANCER AND UNDERWENT LADG (98 PATIENTS; 58 MALE AND 40 FEMALE PATIENTS; AGE: 60.0 ± 1.1; BMI: 23.8 ± 0.3) OR TLDG (98 PATIENTS; 56 MALE AND 42 FEMALE PATIENTS; AGE: 59.6 ± 1.1) BETWEEN MARCH 2010 AND MAY 2016. DURING THE LADG PROCEDURE, THE COMMON ENTRY HOLE WAS CLOSED EXTRACORPOREALLY WITH HAND-SEWN VICRYL 3¿0 (ETHICON) STITCHES. DURING THE TLDG PROCEDURE FOR TUMOR LOCALIZATION, ENDOSCOPY WAS PERFORMED ON THE DAY BEFORE THE SURGERY, AND THE AREA PROXIMAL TO THE TUMOR WAS MARKED USING TWO TO THREE CLIPS. BEFORE GASTRIC TRANSECTION WAS PERFORMED IN THE OPERATION FIELD, CLIPS WERE PLACED ON THE GREATER AND LESSER CURVATURES USING LIGACLIP DEVICES (ETHICON) TO MARK THE ENDPOINT OF THE PLANNED PROXIMAL RESECTION LINE. IN THE LADG GROUP, REPORTED COMPLICATIONS INCLUDED WOUND INFECTION (N-1), INTRA-ABDOMINAL BLEEDING (N-2), LEAKAGE (N-3), AND STENOSIS (N-20). IN THE TLDG GROUP, REPORTED COMPLICATIONS INCLUDED INTRA-ABDOMINAL BLEEDING (N-1), LEAKAGE (N-1), FLUID COLLECTION (N-1), AND STENOSIS (N-1). IT WAS REPORTED THAT ALL MORBIDITIES WERE MANAGED WITH MEDICATION OR INTERVENTION. IN CONCLUSION, THIS STUDY SHOWS THAT TLDG FOR EARLY GASTRIC CANCER IS A SAFE SURGICAL PROCEDURE AND SUPERIOR IN COSMESIS COMPARED WITH LADG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698514 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention