BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGACLIP EXTRA TITANIUM CLIPS

    MDR report key: 17845017 · Received September 29, 2023

    Report

    Report Number
    3005075853-2023-07029
    Event Type
    Injury
    Date Received
    September 29, 2023
    Date of Event
    July 25, 2022
    Report Date
    September 29, 2023
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: 9/29/2023. D4: 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?" 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. 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

    IT WAS REPORTED VIA JOURNAL ARTICLE: TITLE: A NOVEL TECHNIQUE OF SUTURELESS OMENTOPEXY DURING DUAL-INCISION LAPAROSCOPIC PERITONEAL DIALYSIS CATHETER INSERTION TO PREVENT CATHETER DYSFUNCTION DUE TO OMENTAL WRAPPING AUTHOR(S): HAO-WEI KOU, CHUN-NAN YEH, CHUN-YI TSAI, CHAO-WEI LEE, JUN-TE HSU, SHANG-YU WANG, MING-CHIN YU, WEN-HSIN CHEN, CHIEN-CHIH CHIU, TSANN-LONG HWANG CITATION: SURGICAL ENDOSCOPY (2023) 37:148¿155, HTTPS://DOI.ORG/10.1007/S00464-022-09449-7 THE PRESENT STUDY AIMED TO INTRODUCE A SUTURELESS METHOD OF PERFORMING OMENTOPEXY DURING DUAL-INCISION LAPAROSCOPIC PERITONEAL DIALYSIS CATHETER INSERTION. BETWEEN JANUARY 2013 AND MAY 2020, 469 PATIENTS (236 MALES AND 233 FEMALES) WHO UNDERWENT LAPAROSCOPIC PERITONEAL DIALYSIS CATHETER INSERTION WERE INCLUDED IN THE STUDY. THE MEAN AGE OF OUR PATIENT POPULATION WAS 50.3 ± 16.5 YEARS (RANGE, 10¿95 YEARS). THE PATIENTS WERE CATEGORIZED INTO THE OMENTOPEXY (N = 81) AND NON-OMENTOPEXY (N = 388) GROUPS. FOR THE PATIENTS WHO UNDERWENT OMENTOPEXY, THE INFERIOR EDGE OF THE OMENTUM WAS IDENTIFIED AND FIXED TO THE ROUND LIGAMENT OF THE LIVER USING TITANIUM CLIPS (LIGACLIP® EXTRA LIGATING CLIP, LARGE; ETHICON ENDO-SURGERY). THE FIXATION WAS USUALLY REPEATED 3 TO 4 TIMES IN DIFFERENT DIRECTIONS TO KEEP THE OMENTUM AWAY FROM THE PELVIC CAVITY. REPORTED COMPLICATIONS INCLUDED PERSISTENT BLOODY DIALYSATE AND INTRA-ABDOMINAL HEMATOMA AFTER SURGERY (N=1). IN CONCLUSION, SUTURELESS OMENTOPEXY DURING LAPAROSCOPIC PERITONEAL DIALYSIS CATHETER INSERTION IS A SAFE AND RELIABLE TECHNIQUE THAT DOES NOT REQUIRE ADDITIONAL INCISIONS AND SUTURING. ROUTINELY PERFORMING OMENTOPEXY PROVIDES CLINICAL BENEFITS BY REDUCING THE RISK OF CATHETER DYSFUNCTION DUE TO OMENTAL WRAPPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288065 LIGACLIP EXTRA TITANIUM CLIPS CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention