BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36

    MDR report key: 15311917 · Received August 29, 2022

    Report

    Report Number
    3005075853-2022-05645
    Event Type
    Injury
    Date Received
    August 29, 2022
    Date of Event
    January 1, 2020
    Report Date
    August 29, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    LFL
    UDI-DI
    10705036014621
    PMA / PMN Number
    K132612
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE OF EVENT: ONLY EVENT YEAR KNOWN: 2020. 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? 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 FIELD AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/2/2022. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: DOES THE AUTHOR/SURGEON BELIEVE THAT THE ETHICON DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? NO. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: EFFECT OF LAPAROSCOPIC MINIMALLY INVASIVE SURGERY ON COLORECTAL CANCER PATIENTS WITH LIVER METASTASIS. AUTHORS: WANG WENDA, WANG LICHUN, LIU SHIZHOU. CITATION CITE: CHINA CLIN PRAC MED, AUGUST 2020, VOL.11, NO.4. DOI:10.3760/CMA.J.CN115570-20200311.00292. OBJECTIVE OF THIS STUDY IS TO INVESTIGATE THE SAFETY AND EFFICACY OF LAPAROSCOPIC RESECTION OF COLORECTAL CANCER COMBINED WITH LIVER METASTASIS IN PATIENTS WITH COLORECTAL CANCER LIVER METASTASIS. TOTAL OF 42 PATIENTS (25 MALES AND 17 FEMALES, AGED (57.38 ± 2.72) YEARS, AGE RANGE: 41-78 YEARS) WITH CRIM ADMITTED TO THE DEPARTMENT OF COLORECTAL AND ANAL SURGERY, SHANXI CANCER HOSPITAL FROM APRIL 2018 TO JUNE 2019 WERE SELECTED AND DIVIDED INTO LAPAROSCOPE GROUP (N = 18) AND TRADITIONAL LAPAROTOMY GROUP (N = 24) ACCORDING TO DIFFERENT SURGICAL METHODS. THE HARMONIC SCALPEL (ETHICON ENDOSCOPIC SURGERY INSTRUMENTS CO., LTD., MODEL ACE-HARH36) WAS USED TO FREE THE PERIHEPATIC LIGAMENT. THE TUMOR RANGE WAS OBSERVED AND MARKED. THE HARMONIC SCALPEL WAS USED TO REMOVE THE TUMOR ALONG THE MARKED LINE. THE HARMONIC SCALPEL WAS USED TO DISSECT THE VASCULAR RESECTION LESION AT THE ROOT OF PERITONEUM MESENTERY AND OTHER TISSUES. AFTER THE VASCULAR RESECTION LESION AT THE ROOT WAS LIGATED, THE STAPLER (AMERICAN MEDICAL ENDOSCOPIC SURGICAL INSTRUMENTS CO., LTD., MODEL CDH29A/CDH25A; AMERICAN KE HUI CO., LTD., MODEL EEA28) WAS USED FOR END-TO-SIDE ANASTOMOSIS. REPORTED COMPLICATIONS INCLUDED ANASTOMOTIC STOMA PAIN (N=2), SUBPHRENIC INFECTION (N=1), INCISION INFECTION (N=1) IN CONCLUSION IT IS NECESSARY TO STRICTLY CARRY OUT PREOPERATIVE EVALUATION, MASTER THE INDICATIONS OF LAPAROSCOPIC SURGERY, SELECT THE OPTIMAL TREATMENT METHOD ACCORDING TO THE PATIENT'S PRIMARY TUMOR, THE SPECIFIC SITUATION OF METASTASES AND THE MEDICAL LEVEL OF THE REGION WHERE IT IS LOCATED, PREPARE FOR CONVERSION TO LAPAROTOMY AT ANY TIME FOR THE PATIENTS WITH SPECIAL INTRAOPERATIVE CONDITIONS, AND MINIMIZE THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317942 HARMONIC ACE PLUS 7 ADV HEMOSTASIS 36 INSTRUMENT, ULTRASONIC SURGICAL LFL ETHICON ENDO-SURGERY, LLC. HARH36 10705036014621

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention