BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT

    MDR report key: 15601696 · Received October 13, 2022

    Report

    Report Number
    2210968-2022-08426
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    March 2, 2022
    Report Date
    October 13, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FZP
    PMA / PMN Number
    K931492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. 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 SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? 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 NUMBER HAS NOT BEEN PROVIDED. (B)(4). RELATED EVENTS CAPTURED VIA 2210968-2022-08427. CITATION: SEO IY, OH TH. MIGRATION OF LAPRA-TY CLIPS IN URETER AND COLLECTING SYSTEM MIMICKING URINARY STONES FOLLOWING LAPAROSCOPIC PARTIAL NEPHRECTOMY. J UROL SURG, 2022;9(3):209-211. HTTPS://DOI.ORG/10.4274/JUS.GALENOS.2022.2021.0124.

    Description of Event or Problem · 0

    TITLE: MIGRATION OF LAPRA-TY CLIPS IN URETER AND COLLECTING SYSTEM MIMICKING URINARY STONES FOLLOWING LAPAROSCOPIC PARTIAL NEPHRECTOMY. WE PRESENT A RARE CASE OF THE CLIP MIGRATION AFTER LAPAROSCOPIC PARTIAL NEPHRECTOMY(PN) IN WHICH THE CLIPS WERE MISDIAGNOSED AS URINARY STONES. A 57-YEARS-OLD FEMALE PRESENTED WITH RIGHT FLANK PAIN 3 MONTHS AFTER THE SURGERY. A COMPUTED TOMOGRAPHY SCAN SHOWED A 4 MM STONE IN THE LEFT UPPER URETER AND HYDRONEPHROSIS. ANOTHER 3 MM STONE WAS ALSO DETECTED IN THE LEFT UPPER CALYX. RIGID URETEROSCOPY AND FLEXIBLE URETERORENOSCOPY REVEALED TWO LAPRA-TY CLIPS (ETHICON ENDOSURGERY, CINCINNATI, OH, USA), WHICH WERE EMBEDDED IN THE UPPER URETER AND CALYX. THE CLIPS WERE FRAGMENTED BY HOLMIUM LASER LITHOTRIPSY AND REMOVED WITH STONE BASKET. PAIN AND HYDRONEPHROSIS ARE RESOLVED AT FOLLOW-UP. INTRARENAL MOVEMENT OF LAPRA-TY CLIP AFTER PN IS VERY RARE, BUT IT IS POSSIBLE. AS IN OUR CASE, THE MIGRATED CLIPS INTO THE COLLECTING SYSTEM CAN OBSTRUCT THE URETER AND INDUCE SIMILAR SYMPTOMS AND CT FINDINGS OF URINARY STONE. DURING PN, CLEAR OPERATIVE VIEW SHOULD BE ENSURED, AND EXCESSIVE TENSION TO THE SUTURE KNOT SHOULD BE AVOIDED TO PREVENT MIGRATION OF THE CLIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273141 LAPRA-TY SUTURE CLIP UNKNOWN PRODUCT CLIP, IMPLANTABLE FZP ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention