BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 14945442 · Received July 7, 2022

    Report

    Report Number
    2210968-2022-05174
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    May 4, 2021
    Report Date
    July 7, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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/DEATH DESCRIBED IN THE ARTICLE? 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? WOULD THE JOURNAL AUTHOR / PHYSICIAN LIKE TO SPEAK WITH ETHICON MEDICAL SAFETY AND ENGINEERING VIA SCHEDULED CONFERENCE CALL REGARDING THE PRODUCT INVOLVED IN THIS EVENT? 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. COMPONENT CODE: (B)(4) ¿ DEVICE NOT RETURNED THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. RELATED EVENTS CAPTURED VIA 2210968-2022-05171, 2210968-2022-05172, AND 2210968-2022-05173. CITATION CITE: SURGICAL ENDOSCOPY (2022) 36:2341-2348 HTTPS://DOI.ORG/10.1007/S00464-021-08511-0.

    Description of Event or Problem · 0

    TITLE: ENDOSCOPIC PYLOROMYOTOMY IN MINIMALLY INVASIVE ESOPHAGECTOMY: A NOVEL APPROACH. THIS STUDY IS NOT DESIGNED TO STUDY IF PYLORIC DRAINAGE IS BETTER THAN NO-DRAINAGE, BUT RATHER ADDRESSES THE QUESTION IF A NOVEL, TECHNICALLY FACILE, ENDOSCOPIC TECHNIQUE CAN REPLACE A SURGICAL APPROACH IN PATIENTS UNDERGOING MIE IN WHOM A DRAINAGE PROCEDURE IS PLANNED. THIS IS A RETROSPECTIVE ANALYSIS OF A PROSPECTIVELY MAIN­TAINED INSTITUTIONAL DATABASE OF ESOPHAGECTOMIES PERFORMED AT THE THORACIC SURGERY SERVICE IN MCGILL UNIVERSITY HEALTH CENTRE. ALL 94 PATIENTS UNDERGOING MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) FOR CANCER FROM JANUARY 2010 TO DECEMBER 2019 WERE IDENTIFIED. 3-0 PDS SUTURES, HARMONIC SCALPEL AND 3-0 VICRYL SUTURE WERE USED. REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC LEAKAGE (N=10), PULMONARY COMPLICATIONS (N=19) MORTALITY (N=2). IN CONCLUSION ENDOSCOPIC PYLOROMYOTOMY USING A NOVEL APPROACH IS A SAFE, QUICK AND REPRODUCIBLE TECHNIQUE WITH COMPARABLE RESULTS TO A SURGICAL PM IN THE SETTING OF MINIMALLY INVASIVE ESOPHAGECTOMY (MIE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423136 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention