BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 8687009 · Received June 11, 2019

    Report

    Report Number
    3005075853-2019-19636
    Event Type
    Injury
    Date Received
    June 11, 2019
    Report Date
    May 15, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. 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 AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE TITLE: OUTCOME AND RISK FACTORS OF RECURRENCE AFTER THORACOSCOPIC BULLECTOMY IN YOUNG ADULTS WITH PRIMARY SPONTANEOUS PNEUMOTHORAX AUTHORS: TAKASHI NAKAYAMA, YUSUKE TAKAHASHI, HIROFUMI UEHARA, NORIYUKI MATSUTANI, MASAFUMI KAWAMURA CITATION: SURG TODAY. 2017; 47: 859¿864. DOI: 10.1007/S00595-016-1452-Z. THE PURPOSE OF THE STUDY WAS TO INVESTIGATE THE RISK FACTORS OF RECURRENCE OF PNEUMOTHORAX FOLLOWING THORACOSCOPIC BULLECTOMY IN YOUNG ADULTS. BETWEEN JANUARY, 2005 AND SEPTEMBER, 2015, A TOTAL OF 167 PATIENTS AGED = (B)(6) YEARS (154 MALE AND 13 FEMALE PATIENTS; BMI: 49.1 TO 50.9) UNDERWENT INITIAL THORACOSCOPIC BULLECTOMY FOR PRIMARY SPONTANEOUS PNEUMOTHORAX (PSP) AT THE HOSPITAL. DURING THE SURGICAL PROCEDURE, THE AUTHORS PERFORMED THORACOSCOPIC BULLECTOMY USING AN ECHELON ENDOSCOPIC STAPLER (ETHICON) VIA THREE INTERCOSTAL PORT ACCESSES FOR ALL BULLAE DETECTED INTRAOPERATIVELY. REPORTED COMPLICATIONS INCLUDED RECURRENCE OF PNEUMOTHORAX (N-16). IT WAS REPORTED THAT IN GENERAL, PSP IS NOT CONSIDERED A FATAL DISEASE, WITH THE EXCEPTIONS OF SYNCHRONOUS BILATERAL PNEUMOTHORAX AND TENSION PNEUMOTHORAX. THE FINDINGS SHOWED THAT PATIENTS AGED = (B)(6) YEARS AND A HISTORY OF IPSILATERAL PNEUMOTHORAX BEFORE SURGERY HARBOR SIGNIFICANT RISKS OF POST-OPERATIVE RECURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483268 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention