BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN)

    MDR report key: 14592910 · Received June 3, 2022

    Report

    Report Number
    3005075853-2022-03580
    Event Type
    Injury
    Date Received
    June 3, 2022
    Date of Event
    January 1, 2021
    Report Date
    June 8, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PUBLICATION YEAR OF 2021, EXACT EVENT DATE UNK. BATCH # UNK. 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. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORDS CANNOT BE REVIEWED AS THE LOT/BATCH NUMBER HAS NOT BEEN PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 6/8/2022. UPON REVIEW OF THE INFORMATION PROVIDED, IT WAS CONCLUDED THAT THIS EVENT DOES NOT MEET THE FDA DEFINED CRITERIA FOR A REPORTABLE EVENT AND IS BEING CONSIDERED NOT REPORTABLE. ADDITIONAL INFORMATION: CONFIRMED WITH SALES REP, ALL THE ADVERSE EVENTS AND COMPLICATIONS OCCURRED IN THE RESEARCH WERE NOT RELATED TO ETHICON DEVICES. H1.

    Description of Event or Problem · 0

    TITLE: SINGLE-INCISION THORACOSCOPIC SURGERY WITHOUT CHEST TUBE FOR PNEUMOTHORAX IN YOUNG PATIENTS. AUTHORS: ZHANG WEIFENG, REN ZHANLIANG, ZHANG YONG, REN XIAOPENG, HAN YINGJIE. CITATION: HTTP://WWW.CNKI.NET. THIS RETROSPECTIVE STUDY AIMED TO INVESTIGATE THE SAFETY AND FEASIBILITY OF SINGLE-INCISION SINGLE-HOLE THORACOSCOPIC SURGERY WITHOUT CHEST TUBE IN THE TREATMENT OF SPONTANEOUS OR RECURRENT PNEUMOTHORAX IN YOUNG ADULTS. AN UNKNOWN NUMBER OF YOUNG PATIENTS WITH UNILATERAL SPONTANEOUS OR RECURRENT PNEUMOTHORAX WERE INCLUDED IN THIS STUDY. AMONG THEM, A TOTAL OF PATIENTS DID NOT HAVE CLOSED THORACIC DRAINAGE TUBE AFTER OPERATION. EXPERIMENTAL GROUP HAD INDWELLING THORACIC DRAINAGE TUBE. CONTROL GROUP HAD ALL PATIENTS WHO WERE DIAGNOSED WITH LUNG COMPRESSION BY CHEST RADIOGRAPHY OR EXAMINATION BEFORE ADMISSION. HARMONIC SCALPEL OR ELECTRIC HOOK WAS USED TO FREE THE ADHESION BAND, IF THERE IS ANY. JOHNSON & JOHNSON CUTTER STAPLER IS USED TO REMOVE SINGLE BULLAE GREATER THAN MERLOT LIGATION TREATMENT CHART. REPORTED COMPLICATIONS INCLUDE LUNG LEAKAGE (N=?) AND PNEUMOTHORAX (N=?). IN CONCLUSION, UNDER THE PREMISE OF STRICTLY GRASPING THE INDICATIONS, SINGLE-INCISION SINGLE-HOLE THORACOSCOPIC SURGERY WITHOUT CHEST TUBE IS SAFE AND FEASIBLE FOR THE TREATMENT OF UNILATERAL SPONTANEOUS OR RECURRENT PNEUMOTHORAX IN YOUNG PATIENTS AND CAN REDUCE POSTOPERATIVE PAIN AND PROMOTE EARLY AMBULATION TO SHORTEN THE LENGTH OF STAY, REALIZING THE ACCELERATED REHABILITATION OF PATIENTS AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756010 ENDOSCOPIC LNR CUTR (EXACT CODE UNKNOWN) STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention