BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE UNKNOWN

    MDR report key: 23057484 · Received September 15, 2025

    Report

    Report Number
    2210968-2025-10499
    Event Type
    Injury
    Date Received
    September 15, 2025
    Date of Event
    January 23, 2025
    Report Date
    September 15, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: PEDIATR SURG INT. 2025 JAN 23;41(1):70. HTTPS://DOI.ORG/10.1007/S00383-025-05973-4 PMID: 39843772; PMCID: PMC11754325.

    Description of Event or Problem · 0

    TITLE: STAGED THORACOSCOPIC INTERNAL TRACTION APPROACH FOR EARLY REPAIR OF LONG-GAP ESOPHAGEAL ATRESIA (LGEA) WITH DISTAL TRACHEOESOPHAGEAL FISTULA (TEF). THIS STUDY AIMS TO BUILD ON OUR PRIOR CASE SERIES, DESCRIBE OUR OPERATIVE TECHNIQUE IN MORE DETAIL, AND STUDY BOTH THE SHORT AND LONG-TERM OUTCOMES OF OUR APPROACH. BETWEEN 2018 AND 2024, SEVEN PATIENTS UNDERWENT A THORACOSCOPIC REPAIR OF THEIR TYPE III/C LGEA USING A STAGED APPROACH WITH A SHORT INTERVAL OF INTERNAL TRACTION USING 5¿0 OR 6¿0 PDS OR PROLENE SUTURES. REPORTED COMPLICATIONS ARE SUTURE UNKNOWN (5¿0 OR 6¿0 PDS OR PROLENE SUTURES) PATIENT 1: (36 WEEKS, FEMALE) ESOPHAGEAL STENOSIS BY 6 MONTHS OF AGE TREATMENT: REQUIRING A SINGLE ENDOSCOPIC DILATION. IN CONCLUSION, THIS DEMONSTRATED THAT A STAGED, INTERNAL TRACTION APPROACH TO REPAIRING LGEA WITH A DISTAL FISTULA CAN BE SUCCESSFULLY PERFORMED THORACOSCOPICALLY, IN TWO STAGES, WITH A SHORT-INTERVAL OF INTERNAL TRACTION, AND WITHOUT THE USE OF ANY G-TUBE. THE RATES OF POST-OPERATIVE COMPLICATIONS, INCLUDING LEAKS, STRICTURES, AND GERD, AFTER THIS MINIMALLY INVASIVE APPROACH ARE ENCOURAGING AND SUGGEST THAT THE PRESENCE OF THIS CLASSICALLY CHALLENGING VARIANT OF EA, SHOULD NOT DISCOURAGE THE USE OF THORACOSCOPY FOR REPAIR. THIS APPROACH CHALLENGES THE CURRENT PARADIGM THAT ALL TYPE III/C ESOPHAGEAL ATRESIA CASES MUST BE REPAIRED WITH A PRIMARY ANASTOMOSIS IN A SINGLE SURGERY. INSTEAD, IT DEMONSTRATES THAT A STAGED APPROACH IS FEASIBLE FOR LONG-GAP TYPE III/C ATRESIA, ALLOWING FOR A SAFER ANASTOMOSIS WITH REDUCED TENSION, THEREBY IMPROVING SURGICAL OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022210 SUTURE UNKNOWN SUTURE, NONABSORBABLE GAO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO Female Required Intervention