BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN)

    MDR report key: 13505229 · Received February 10, 2022

    Report

    Report Number
    3005075853-2022-00754
    Event Type
    Injury
    Date Received
    February 10, 2022
    Date of Event
    January 2, 2021
    Report Date
    February 10, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNKNOWN. 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/BATCH NUMBER HAS NOT BEEN PROVIDED. 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 DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FIELD AS APPROPRIATE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: POLYGLYCOLIC ACID MESH FOR PREVENTING POST-THORACOSCOPIC BULLECTOMY RECURRENCE. AUTHORS: EIJI MIYAHARA, DAISUKE UEDA, YUKARI KAWASAKI, YASUTOMO OJIMA, ATSUO KIMURA, TSUNEO OKUMICHI. CITATION CITE: SURGERY TODAY (2021) 51:971¿977 HTTPS://DOI.ORG/10.1007/S00595-020-02191-4. THIS RETROSPECTIVE STUDY COMPARED THE RECURRENCE RATE OF PNEUMOTHORAX FOLLOWING CONVENTIONAL THORACOSCOPIC BULLECTOMY TO THAT FOLLOWING BULLECTOMY USING A LOW-DENSITY POLYGLYCOLIC ACID MESH TO COVER THE STAPLE LINE. GROUP A COMPRISED 237 PATIENTS WHO EXPERIENCED 294 EPISODES OF PNEUMOTHORAX AND UNDERWENT THORACOSCOPIC BULLECTOMY ALONE, AND GROUP B COMPRISED 130 PATIENTS WHO EXPERIENCED 155 EPISODES OF PNEUMOTHORAX AND UNDERWENT BULLECTOMY WITH POLYGLYCOLIC ACID MESH USED TO COVER THE VISCERAL PLEURA. TO COMPARE THE POSTOPERATIVE INFLAMMATORY RESPONSE BETWEEN THE TWO GROUPS, THE SURGEONS MEASURED THREE INFLAMMATORY PARAMETERS: HIGHEST BODY TEMPERATURE AFTER SURGERY, C-REACTIVE PROTEIN LEVEL ON POSTOPERATIVE DAY 3, AND CHANGE IN EOSINOPHIL COUNT FROM THE DAY BEFORE THE SURGERY TO POSTOPERATIVE DAY 3. ENDOPATH STAPLER. [JOHNSON & JOHNSON, NEW BRUNSWICK, NJ, USA] WAS USED IN GROUP A. REPORTED COMPLICATIONS INCLUDED POSTOPERATIVE RECURRENT PNEUMOTHORAX (N=47) AND INFLAMMATORY, PROLONGED AIR LEAKAGE, NEW BULLAE. IN CONCLUSION USING A POLYGLYCOLIC ACID MESH COVERING AFTER THORACOSCOPIC BULLECTOMY RESULTED IN ACCEPTABLE LONG-TERM RESULTS (RECURRENCE RATE: 2.6%). THIS METHOD WAS ASSOCIATED WITH A SLIGHTLY ELEVATED INFLAMMATORY RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85408 ENDOPATH*STEALTH CIR STAPLER (EXACT CODE UNKNOWN) LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown