BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON 60

    MDR report key: 8687543 · Received June 11, 2019

    Report

    Report Number
    3005075853-2019-19638
    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: EVALUATION OF THE NECESSITY FOR CHEST DRAIN PLACEMENT FOLLOWING THORACOSCOPIC WEDGE RESECTION AUTHORS: TING-YU LU, JIAN-XUN CHEN, PIN-RU CHEN, YU-SEN LIN, CHIEN-KUANG CHEN, PEI-YU KAO, TZU-MING HUANG, HSIN-YUAN FANG, CITATION: SURG TODAY (2017); 47:606¿610. DOI: 10.1007/S00595-016-1414-5. THIS RETROSPECTIVE STUDY WAS CONDUCTED TO EVALUATE THE OUTCOMES OF PATIENTS WHO UNDERWENT THORACOSCOPIC WEDGE RESECTION WITHOUT CHEST DRAIN PLACEMENT. THE SUBJECTS OF THIS RETROSPECTIVE STUDY WERE 89 PATIENTS, WHO UNDERWENT THORACOSCOPIC WEDGE RESECTION BETWEEN JANUARY, 2013 AND JULY, 2015. THE PATIENTS WERE DIVIDED INTO TWO GROUPS: IN ¿CHEST DRAIN PLACEMENT GROUP¿ (GROUP A), 45 PATIENTS (21 MALE AND 24 FEMALE; MEAN AGE: 56.98 ± 16.33 YEARS) HAD AN UNDERLYING CONDITION THAT DID NOT MEET THE FOLLOWING CRITERIA OF PERIPHERAL LESIONS, HEALTHY LUNG PARENCHYMA, NO INTRAOPERATIVE AIR LEAKS, HEMORRHAGE OR EFFUSION ACCUMULATION, AND NO PLEURAL ADHESION. THE OTHER 44 PATIENTS (21 MALE AND 23 FEMALE; MEAN AGE: 54.14 ± 12.94 YEARS) WHOSE UNDERLYING CONDITION MET THE CRITERIA WERE ASSIGNED TO THE ¿NO CHEST DRAIN PLACEMENT GROUP¿ (GROUP B). A LUNG PARENCHYMA RESECTION WAS PERFORMED WITH ECHELON FLEX ENDOPATH STAPLERS 3.5/4.1 MM STAPLE HEIGHT (ETHICON). REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE SUBCUTANEOUS EMPHYSEMA (N-24 IN GROUP A AND N-15 IN GROUP B) AND INTOLERABLE PAIN (N-? IN BOTH GROUPS) IN WHICH THE PATIENTS WERE PROVIDED WITH INTRAMUSCULAR OPIOID (MEPERIDINE 30 MG, WITH A MINIMUM 6 H INTERVAL). IN CONCLUSION, AVOIDING CHEST DRAIN PLACEMENT AFTER A THORACOSCOPIC WEDGE RESECTION APPEARS TO BE SAFE AND BENEFICIAL FOR PATIENTS WHO HAVE SMALL PERIPHERAL LESIONS AND HEALTHY LUNG PARENCHYMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480034 ECHELON 60 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention