BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19127560 · Received April 17, 2024

    Report

    Report Number
    2210968-2024-04458
    Event Type
    Injury
    Date Received
    April 17, 2024
    Date of Event
    October 6, 2023
    Report Date
    April 17, 2024
    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 · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: UROL INT 2023;107:901¿909. DOI: 10.1159/000532129. HTTPS://DOI.ORG/10.1159/000532129.

    Description of Event or Problem · 0

    TITLE: DOUBLE-LAYERED HAND-SEWN VERSUS STAPLED INTESTINAL ANASTOMOSIS IN PATIENTS WHO UNDERWENT ILEAL URINARY DIVERSION IN RADICAL CYSTECTOMY: A COMPARATIVE AND COST EFFECTIVE STUDY. THE AIM OF THIS RETROSPECTIVE COMPARATIVE STUDY WAS TO COMPARE GASTROINTESTINAL (GI) COMPLICATIONS, OPERATIVE TIME, AND COSTS OF THE DOUBLE-LAYER INTESTINAL ANASTOMOSIS PERFORMED WITH THE TWO TECHNIQUES. BETWEEN JANUARY 2016 TO MAY 2021, A TOTAL OF 195 PATIENTS [MEAN AGE WAS 71 YEARS (RANGE 67¿77 YEARS); MEAN BMI WAS 26 (23.6¿29.0) KG/M2] WHO UNDERWENT RADICAL CYSTECTOMY AND URETERO-ILEO-CUTANEOSTOMY OR VESCICA ILEALE PADOVANA ORTHOTOPIC NEOBLADDER WERE INCLUDED IN THE STUDY. THE MESENTERY INCISION WAS USUALLY PERFORMED USING THE HARMONIC FOCUS® LONG SHEARS (ETHICON ENDO-SURGERY INC., CINCINNATI,OH, USA) OR THE LIGASURE¿ MARYLAND JAW (COVIDIEN, MANSFIELD, MA, USA). AMONG THE PATIENTS, 100 (51.3%) OF THEM RECEIVED A DOUBLE-LAYERED HAND-SEWN INTESTINAL ANASTOMOSIS (HS-IA) USING VICRYL STITCHES (TWO 4.0 VICRYL FOR THE MUCOSA LAYER AND TWO 3.0 VICRYL FOR THE SEROSA LAYER), AND THE REMAINING 95 (48.7%), A MECHANICAL-STAPLED INTESTINAL ANASTOMOSIS (MS-IA) WERE PERFORMED WITH A MECHANICAL STAPLER (COMPETITOR) AND INTERRUPTED 3-0 VICRYL STITCHES WERE PLACED EXTERNALLY TO REENFORCE THE MECHANICAL SUTURES ANTERIORLY (6 STITCHES), POSTERIORLY (6 STITCHES), AND SUPERIORLY (4 STITCHES). THE MESENTERY WINDOW WAS CLOSED WITH INTERRUPTED SUTURES. IN CASE OF ILEAL CONDUIT, THE DISTAL END OF THE ILEAL SEGMENT IS CLOSED WITH DOUBLE HAND-SEWN TECHNIQUE OR WITH LINEAR STAPLER. THE URETERS ARE SPATULATED AND ANASTOMOSED WITH END TO SIDE ANASTOMOSIS (BRICKER TECHNIQUE), TAKING INTERRUPTED FULL-THICKNESS BITES OF BOTH THE URETER AND BOWEL USING 4.0 VICRYL. THE STOMA IS FIXED TO THE SHEATH WITH VICRYL. REPORTED COMPLICATIONS INCLUDE INTRAOPERATIVE COMPLICATIONS (N=12), UNKNOWN EVENT REQUIRING INTRAOPERATIVE BLOOD TRANSFUSION (N=15), CLAVIEN-DINDO COMPLICATIONS GRADE 1 TO 4 INCLUDING MOST COMMON COMPLICATION FEVER AND ANEMIA (N=?), GI COMPLICATIONS SUCH AS PARALYTIC ILEUS (N=3), CONSTIPATION (N=2), SMALL BOWEL OBSTRUCTION (N=2), GI BLEEDING (N=1), EMESIS (N=1), ANASTOMOTIC BOWEL LEAK (N=1), BOWEL PERFORATION (N=2), PERITONITIS (N=1). IN CONCLUSION, HS-IA AND MS-IA INTESTINAL SUTURES TECHNIQUES ARE EQUALLY SAFE AND EFFECTIVE FOR PATIENTS. NO DIFFERENCES ARE REPORTED IN THE POSTOPERATIVE COURSE. HANDMADE ILEO-ILEAL ANASTOMOSIS IS AN IMPORTANT COST-SAVING APPROACH COMPARED TO THE STAPLED ALTERNATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1892878 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention