BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 17885072 · Received October 6, 2023

    Report

    Report Number
    2210968-2023-07481
    Event Type
    Injury
    Date Received
    October 6, 2023
    Date of Event
    February 19, 2023
    Report Date
    October 6, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (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. RELATED EVENTS CAPTURED VIA 2210968-2023-07477, 2210968-2023-07478, 2210968-2023-07479, 2210968-2023-07480, 2210968-2023-07482, 2210968-2023-07483, 2210968-2023-07484, 2210968-2023-07485. HTTPS://DOI.ORG/10.1111/CODI.16528.

    Description of Event or Problem · 0

    TITLE: AN EARLY EXPERIENCE IN ROBOTIC LLEOANAL POUCH SURGERY WITH ROBOTIC INTRACORPOREAL SINGLE STAPLED ANASTOMOSIS (RISSA) AT A TERTIARY REFERRAL CENTRE. THE OBJECTIVE OF THIS STUDY IS TO DESCRIBE THE SAFETY AND EARLY OUTCOMES OF ROBOTIC INTRACORPOREAL SINGLE-STAPLED ANASTOMOSIS (RISSA) AMONGST PATIENTS OPERATED CONSECUTIVELY AT A TERTIARY CENTRE IMMEDIATELY BEFORE AND FOLLOWING THE PANDEMIC. BETWEEN OCTOBER 2019 TO OCTOBER 2022, A TOTAL OF 20 CONSECUTIVE PATIENTS (NINE WITH ULCERATIVE COLITIS AND 11 WITH FAMILIAL ADENOMATOUS POLYPOSIS) WERE INCLUDED WITH A MEDIAN AGE OF 25 YEARS (RANGE 16¿52); 18 HAD AMERICAN SOCIETY OF ANESTHESIOLOGISTS CLASSIFICATION II, AND MEAN BODY MASS INDEX WAS 24 KG/M2 (RANGE 18.1¿34.3). NINE PATIENTS (EIGHT ULCERATIVE COLITIS AND ONE FAMILIAL ADENOMATOUS POLYPOSIS) HAD UNDERGONE PRIOR SUBTOTAL COLECTOMY AND THEREFORE UNDERWENT RESTORATIVE PROCTECTOMY WITH IPAA. ELEVEN PATIENTS UNDERWENT RESTORATIVE PROCTOCOLECTOMY. ALL PATIENTS ARE AMENABLE TO ILEOSTOMY REVERSAL AND, IN CONSEQUENCE, RESTORATION OF CONTINUITY. TO DATE, THE MAJORITY, 70% (14/20), OF PATIENTS HAVE HAD THEIR ANASTOMOSIS CHECKED POSTOPERATIVELY WITH A POUCHOGRAM AND POUCHOSCOPY BUT OTHER MODALITIES SUCH AN EXAMINATION UNDER ANAESTHESIA WERE ALSO USED. ALL PATIENTS WILL REQUIRE SUCCESSFUL POUCHOGRAPHY PRIOR TO REVERSAL. TO DATE SEVEN PATIENTS HAVE SUCCESSFULLY HAD THEIR ILEOSTOMY REVERSED. A 2¿0 POLYPROPYLENE PURSE-STRING IS MADE AT THE MARGIN OF THE ENTEROTOMY TO SECURE THE ANVIL OF THE CIRCULAR STAPLER AT THE APEX OF THE POUCH AND THIS IS RETURNED TO THE PERITONEAL CAVITY. A 29-MM ECHELON CIRCULAR POWERED STAPLER (ETHICON) IS INSERTED THROUGH THE ANUS AND THE SPIKE IS EXTENDED FULLY. FIRST THE PROXIMAL AND THEN THE DISTAL PURSE-STRING SUTURES ARE TIED AND TIGHTENED OVER THE SPIKE. THE ANASTOMOTIC INTEGRITY IS ULTIMATELY INSPECTED VIA THE ANUS USING A PERINEAL RETRACTOR AND THE STAPLE LINE IS REINFORCED WITH 10¿12 TRANSANAL MUCOSA¿MUCOSA 3¿0 VICRYL SUTURES. REPORTED COMPLICATIONS INCLUDED HIGH OUTPUT STOMA (N=3), DRAIN COMPLICATION (N=1), WOUND INFECTION (N=1), SURGICAL STOMA REVISION (N=1), PELVIC SEPSIS AND IPAA DEFECT (N=1), SMALL BOWEL OBSTRUCTION (N=1). IN CONCLUSION, WE PRESENT AN EARLY CASE SERIES WHERE WE DEMONSTRATE THE EFFICACY OF OUR ROBOTIC APPROACH TO IPAA SURGERY WITH RISSA WITH ACCEPTABLE QUALITY AND SAFETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071884 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention