BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIP - EXACT CODE UNKNOWN

    MDR report key: 15674603 · Received October 26, 2022

    Report

    Report Number
    3005075853-2022-07256
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    May 4, 2022
    Report Date
    November 16, 2022
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K830503
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 DEVICES MENTIONED IN THIS ARTICLE CAUSED/CONTRIBUTED TO THE REPORTED EVENTS IN THE ARTICLE? INVESTIGATION SUMMARY: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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.

    Additional Manufacturer Narrative · 0

    (B)(4).DATE SENT: 11/16/2022 UPON FURTHER REVIEW OF THE EVENT BY ETHICON MEDICAL, CLINICAL CODE E0619 HAS BEEN REMOVED AS THERE NO MENTION OF THIS ADVERSE EVENT IN THE REPORTED EVENT DESCRIPTION. H6: HEALTH EFFECT - CLINICAL CODE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA JOURNAL ARTICLE; TITLE: LAPAROSCOPIC ANATOMICAL VERSUS NON-ANATOMICAL HEPATECTOMY IN THE TREATMENT OF HEPATOCELLULAR CARCINOMA: A RANDOMISED CONTROLLED TRIAL. AUTHORS: KEXI LIAO A, KAIJIN YANG A,B, LI CAO A, YAO LU A, BOWEN ZHENG A, XUESONG LI A, XIAOJUN WANG A, JIANWEI LI A, JIAN CHEN A, SHUGUO ZHENG A,* CITATION: INTERNATIONAL JOURNAL OF SURGERY (2022);102 (106652):1-8. HTTPS://DOI.ORG/10.1016/J.IJSU.2022.106652. A PROSPECTIVE RANDOMISED CONTROLLED TRIAL (RCT) WAS CONDUCTED TO COMPARE THE PERIOPERATIVE AND FOLLOW-UP OUTCOMES OF PATIENTS WITH HEPATOCELLULAR CARCINOMA (HCC) TREATED BY LAPAROSCOPIC ANATOMICAL HEPATECTOMY (LAH) AND NON-ANATOMICAL HEPATECTOMY (LNAH). BETWEEN MARCH 2013 AND JAN 2018, A TOTAL OF 385 PATIENTS WITH A DIAGNOSIS OF HCC WERE INCLUDED IN THE STUDY. AMONG THESE, 192 PATIENTS (161 MALE AND 31 FEMALE; MEAN AGE OF 52.92 ± 11.30 YEARS) UNDERWENT LAH AND 193 (168 MALE AND 25 FEMALE; MEAN AGE OF 51.75 ± 10.64 YEARS) UNDERWENT LNAH. SURGERY WAS PERFORMED USING ULTRASONIC SCALPEL (ETHICON ENDO-SURGERY, CINCINNATI, OH), VASCULAR CLIPS (CONTINUOUS TITANIUM CLIPS, ETHICON ENDO-SURGERY), AND ENDOSCOPIC LINEAR CUTTER (ECHELON 45/60 ENDOPATH STAPLER, USA). REPORTED COMPLICATIONS INCLUDE CONVERSION TO LAPAROTOMY DUE TO RIGHT HEPATIC VEIN INJURY (N=6), MIDDLE HEPATIC VEIN INJURY (N=6), UNCONTROLLED HAEMORRHAGE/MASSIVE BLEEDING DURING PARENCHYMAL TRANSECTION (N=5); HEPATIC INSUFFICIENCY (N=3); BILIARY LEAKAGE (N=12); PERITONEAL ENCAPSULATED EFFUSION (N=14); ASCITES (N=2); WOUND INFECTION (N=2). IN CONCLUSION, LAH VERSUS LNAH FOR SELECTED HEPATOCELLULAR CARCINOMA (HCC) PATIENTS WAS ASSOCIATED WITH INCREASED DISEASE-FREE SURVIVAL (DFS), LOWER INTRAHEPATIC IPSILATERAL RECURRENCE RATE, COMPARABLE LONG-TERM OS AND POSTOPERATIVE COMPLICATIONS. LAH IS THEREFORE RECOMMENDED FOR SELECTED HCC PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510373 CLIP - EXACT CODE UNKNOWN CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention