BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE 5MM SHEAR

    MDR report key: 12308238 · Received August 11, 2021

    Report

    Report Number
    3005075853-2021-04642
    Event Type
    Injury
    Date Received
    August 11, 2021
    Date of Event
    August 27, 2020
    Report Date
    July 13, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    PMA / PMN Number
    K120729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/8/2021. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT COMPLICATIONS MENTIONED IN THE ARTICLE? IF YES, PLEASE EXPLAIN THE SURGEON DOES NOT BELIEVE THAT. 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 Manufacturer Narrative · 1

    (B)(4). PUBLICATION YEAR OF 2020. BATCH # UNK. (B)(4). 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.

    Description of Event or Problem · 1

    TITLE: COMPARISON OF SINGLE-PORT VS. TWO-PORT VATS TECHNIQUE FOR PRIMARY SPONTANEOUS PNEUMOTHORAX, AUTHORS: PEIJIE WANG, LIANG ZHANG, HONGJIE ZHENG, DONGQING YAN, HAIYANG FAN, HONGSEN LIANG, JUNHANG ZHANG & YUN LI, CITATION: MINIMALLY INVASIVE THERAPY & ALLIED TECHNOLOGIES. THE PURPOSE OF THIS RETROSPECTIVE STUDY IS TO ANALYZE OUR SINGLE CENTER¿S EXPERIENCE TO EVALUATE THE FEASIBILITY AND ADVANTAGES OF SINGLE-PORT COMPARED WITH TWO-PORT VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) IN TREATING PRIMARY SPONTANEOUS PNEUMOTHORAX (PSP) PATIENTS. FROM JANUARY 2017 TO DECEMBER 2018, 104 PATIENTS WITH PSP UNDERWENT VATS. FIFTY-SIX PATIENTS RECEIVED SINGLE-PORT VATS AND 48 PATIENTS RECEIVED TWO-PORT VATS. THE MEAN AGE WAS 24.65 ± 0.48 YEARS (RANGE 15¿40). MEAN BODY MASS INDEX (BMI) WAS 18.48 ± 0.25 KG/M2 (RANGE 14.5¿29.1). THERE WERE 92 MALE PATIENTS AND 44 SMOKERS. THE IMPLANTS USED WERE AN ENDOSCOPIC LINEAR STAPLER (PSE45A, ETHICON ENDO-SURGERY, LLC. GUAYNABO, PR) AND A HARMONIC SCALPEL (ETHICON ENDO SURGERY INC ¿ JOHNSON & JOHNSON MEDICAL SPA, SOMERVILLE, NJ). (N=4) PROLONGED AIR LEAKAGE. ONE PATIENT RECOVERED AFTER PERFORMING CHEMICAL PLEURODESIS USING 50% GLUCOSE SOLUTION. THE OTHER 3 HAVE BEEN MANAGED CONSERVATIVELY AND RESOLVED SPONTANEOUSLY. (N=4) MILD PLEURAL EFFUSION. THESE PATIENTS WERE TREATED CONSERVATIVELY. PLEURAL EFFUSION WAS ABSORBED WHEN THEY WERE FOLLOWED UP ON THE FIRST MONTH AFTER DISCHARGE. (N=41) CHEST WALL PARESTHESIA. (N=3) IPSILATERAL RECURRENCE. ALL PATIENTS RECOVERED WITH CHEST DRAINAGE AND CHEMICAL PLEURODESIS. COMPARED WITH TWO-PORT VATS, SINGLE-PORT VATS FOR PSP SHOWED MORE FAVORABLE RESULTS IN TERMS OF POSTOPERATIVE PARESTHESIA AND PAIN. THE SINGLE-PORT PROCEDURE MAY BE CONSIDERED A GOOD ALTERNATIVE TO THE STANDARD THORACOSCOPIC TREATMENT OF PSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1204747 HARMONIC ACE 5MM SHEAR INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention