BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 19059216 · Received April 8, 2024

    Report

    Report Number
    2210968-2024-03984
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    May 23, 2022
    Report Date
    April 8, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. RELATED EVENTS CAPTURED VIA 2210968-2024-03985. CITATION: HEAD & NECK. 2022. HTTPS://DOI.ORG/10.1002/HED.27114.

    Description of Event or Problem · 0

    TITLE: THE ROBOTIC-ASSISTED EXTENDED ¿SISTRUNK¿ APPROACH FOR TUMORS OF THE UPPER AERODIGESTIVE TRACT WITH LIMITED TRANSORAL ACCESS: FIRST DESCRIPTION OF ONCOLOGICAL AND FUNCTIONAL OUTCOMES. THE AIM OF THIS STUDY IS TO ASSESS THE IMPACT OF THE RESA APPROACH BY EVALUATING QUALITY OF EXPOSURE, SURGICAL MARGINS, AND FUNCTIONAL SPEECH AND SWALLOWING RECOVERY OF SIX PATIENTS WITH CANCERS CONFINED TO THE SUPRAGLOTTIS, PIRIFORM SINUS, POSTCRICOID REGION, AND BASE-OF-TONGUE; THREE PATIENTS HAD PREVIOUS RADIATION (RT) OR CHEMORADIATION (CRT) THAT WERE NEITHER EXPOSABLE FOR TRANSORAL LASER (TLM) NOR TRANSORAL ROBOTIC SURGERY (TORS). INCLUDED IN THIS STUDY ARE A TOTAL OF SIX PATIENTS UNDERWENT A TUMOR RESECTION USING THE RESA TECHNIQUE. ALL PATIENTS HAD BEEN TRACHEOTOMIZED. ALL PATIENTS WERE MALE AND THE MEAN AGE WAS 63.7 YEARS (RANGE 52¿90). DURING THE PROCEDURE, THE CLOSURE IS PERFORMED IN THREE LAYERS USING 3.0 VICRYL SUTURES FIRST CLOSING THE MUCOSA OF THE VALLECULA, THEN REAPPROXIMATING THE INNER AND OUTER LAYER OF THE SUPRA- AND INFRAHYOID MUSCULATURE. A SIMPLE REDON IS THEN PLACED IN THE WOUND AND THE SKIN CLOSED USING STAPLES OR 5.0 PROLENE. REPORTED COMPLICATION: BLEEDING (N-3). CONCLUSION: THIS STUDY DEMONSTRATES THAT USING RESA LEADS TO LAR YNX PRESERVATION AND MAY HELP TO AVOID OPEN SURGERY IN PATIENTS NEEDING SALVAGE RESECTIONS. CONSIDERING LARGE PROSPECTIVE RANDOMIZED ORGAN PRESERVATION TRIALS, THAT IS, RTOG 91-11, LARYNX PRESERVATION RANGES BETWEEN 64% AND 82% AT 10 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107653 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Required Intervention