BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 22381619 · Received July 2, 2025

    Report

    Report Number
    2210968-2025-07645
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    September 12, 2024
    Report Date
    August 5, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: SURG ENDOSC. 2024 OCT;38(10):6177-6183. HTTPS://DOI.ORG/10.1007/S00464-024-11246-3. EPUB 2024 SEP 12. PMID: 39266762.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). CORRECTED INFORMATION: B1, B2, H1 - ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENTS. THEREFORE, THIS MEDWATCH REPORT IS BEING VOIDED.

    Description of Event or Problem · 0

    TITLE: APPLICATION OF MODIFIED EXTRA LEVATOR ABDOMINOPERINEAL EXCISION FOR LOW RECTAL CANCER RESECTION. THE AIM OF THIS STUDY IS TO COMPARE CONVENTIONAL ELAPE OPERATION WITH MODIFIED ELAPE OPERATION TO INVESTIGATE THE EFFICACY AND SAFETY OF MODIFIED ELAPE OPERATION. BETWEEN 2017 TO 2021, A TOTAL OF 339 PATIENTS WITH LOW RECTAL CANCER UNDERGOING ABDOMINOPERINEAL RESECTION. PATIENTS WERE CLASSIFIED INTO MODIFIED ELAPE GROUP (199 PATIENTS) USING 1¿0 SILK SUTURES (ETHICON) AND CONVENTIONAL ELAPE GROUP (140 PATIENTS). REPORTED COMPLICATIONS ARE N=12; POSTOPERATIVE PERISTOMAL HERNIA TREATMENT: NOT MENTIONED N=9; POSTOPERATIVE PERINEAL HERNIA TREATMENT: NOT MENTIONED N=10; POSTOPERATIVE LOCAL RECURRENCE TREATMENT: NOT MENTIONED N=13; POSTOPERATIVE LIVER/LUNG METASTASIS TREATMENT: NOT MENTIONED. IN CONCLUSION, MODIFIED ELAPE SURGERY IS TECHNICALLY SAFE AND FEASIBLE, AND ONCOLOGICALLY COMPARABLE TO THAT OF CONVENTIONAL ELAPE SURGERY, WHICH CAN BE CONSIDERED FOR POPULARIZATION AND APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142231 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other