BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON ENDOPATH STAPLER

    MDR report key: 15703993 · Received October 31, 2022

    Report

    Report Number
    3005075853-2022-07433
    Event Type
    Injury
    Date Received
    October 31, 2022
    Date of Event
    April 18, 2022
    Report Date
    October 31, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: PUBLICATION YEAR OF 2022 EXACT DATE UNK. BATCH # UNK. 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. 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 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    TITLE: SIMULTANEOUS COMPARISON OF SUBXIPHOID AND INTERCOSTAL WOUND PAIN IN THE SAME PATIENTS FOLLOWING THORACOSCOPIC SURGERY. AUTHORS: YU-WEI LIU. SHAH-HWA CHOU, ANDRE CHOU, AND CHIEH-NI KAO. CITATION: J. CLIN. MED. 2022, 11, 2254, HTTPS://DOI.ORG/10.3390/JCM11082254. THIS STUDY ASSESSED REPORTED PAIN AT SIX POSTOPERATIVE TIME POINTS IN THE SAME PATIENTS RECEIVING BOTH SUBXIPHOID AND INTERCOSTAL INCISIONS FOR THORACIC DISEASE. FROM AUGUST 2019 TO JULY 2021, 44 PATIENTS WHO RECEIVED SIMULTANEOUS COMBINED INTERCOSTAL AND SUBXIPHOID VIDEO-ASSISTED THORACOSCOPIC SURGERY WERE INCLUDED IN THE STUDY. THERE WERE 26 MALES AND 18 FEMALES WITH A MEAN AGE OF 52 YEARS (RANGE, 18-76 YEARS) AND A MEAN BMI OF 23 KG/M2 (RANGE 16.5-30 KG/M2). DURING THE PROCEDURE, SURGICAL EQUIPMENT INCLUDED ECHELON FLEX ENDOSCOPIC ARTICULATING LINEAR CUTTERS (ETHICON ENDO-SURGERY) WHICH WAS USED TO TRANSECT THE BASAL TRUNK OF PULMONARY ARTERY AND RIGHT LOWER LOBE BRONCHUS VIA SUBXIPHOID INCISION. A HARMONIC SCALPEL (ETHICON ENDO-SURGERY) WAS USED TO DISSECT UPPER MEDIASTINAL LYMPH NODES FROM 5TH INTERCOSTAL INCISION. COMPETITORS¿ DEVICES SUCH AS LONG CURVED DISSECTOR, GRASPING FORCEPS, CURVED SUCTION (MANUFACTURER: SCALAN INTERNATIONAL), THORACOSCOPE (MANUFACTURER: KARL STORZ), AND PLASTIC WOUND PROTECTOR (MANUFACTURER: APPLIED MEDICAL) WERE ALSO USED. PAIN SCORES FOR BOTH SUBXIPHOID AND INTERCOSTAL WOUNDS WERE SIMULTANEOUSLY ASSESSED POSTOPERATIVELY USING NUMERICAL RATING SCALE, 0 (NO PAIN) TO 10 (EXCRUCIATING PAIN), EVERY EIGHT HOURS WITH PATIENT AT REST ON POSTOPERATIVE DAY 1 AND THEN ON SUBSEQUENT POSTOPERATIVE DAYS UNTIL DISCHARGE. THE REPORTED COMPLICATIONS INCLUDED PROLONGED AIR LEAK OF MORE THAN 5 DAYS (N=2), AND POSTOPERATIVE PAIN (N=?). IN CONCLUSION, OUR STUDY FOUND THAT PATIENTS WHO RECEIVED SIMULTANEOUS UNIPORTAL IPSILATERAL SUBXIPHOID VIDEO-ASSISTED THORACOSCOPIC SURGERY AND CONTRALATERAL INTERCOSTAL VIDEO-ASSISTED THORACOSCOPIC SURGERY REPORTED MORE PAIN ASSOCIATED WITH SUBXIPHOID INCISIONS THAN INTERCOSTAL INCISIONS. THUS, THE USE OF SUBXIPHOID VIDEO-ASSISTED THORACOSCOPIC SURGERY MAY NOT ALWAYS RESULT IN GREATER PAIN REDUCTION THAN INTERCOSTAL INCISIONS IN THE EARLY POSTOPERATIVE PERIOD. ADDITIONALLY, THE HIGHER PAIN INTENSITY IN THE INTERCOSTAL INCISIONS REPORTED IN THE LATE POSTOPERATIVE PERIOD MAY NOT BE INDICATIVE OF PAIN CAUSED BY MERELY NERVE DAMAGE DURING SURGERY, AS THERE WERE OTHER POTENTIAL MULTIFACTORIAL PAIN-CAUSING OR PAIN-WORSENING MECHANISMS SUCH AS ADJUNCTIVE CHEMOTHERAPY AND/OR RADIOTHERAPY INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2296663 ECHELON ENDOPATH STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention