BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPRA-TY ABSORBABLE X6::SUTURE CLIP

    MDR report key: 17113772 · Received June 12, 2023

    Report

    Report Number
    2210968-2023-04246
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 16, 2023
    Report Date
    June 12, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    FZP
    UDI-DI
    10705031206885
    PMA / PMN Number
    K931492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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 HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 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. HOW MANY DEVICES HAD THE ISSUE? PLEASE PROVIDE QUANTITY. WHAT SUTURE SIZE WAS USED? WHEN THE EVENT OCCURRED, WAS THE SUTURE PLACED NEAR THE HINGE OF THE CLIP? WERE YOU ABLE TO LOCK THE CLIP CLOSED ON THE SUTURE? IF YES AFTER IT CLOSED, WAS THE CLIP HOLDING SECURELY FIXED ON THE SUTURE? WAS THE APPLIER CHECKED FOR DAMAGE (JAWS STRAIGHT AND ALIGNED)? IF CLIP DID NOT CLOSE/DID NOT HOLD ON THE SUTURE, WAS THE CLIP USED IN AN APPLICATION WHERE THE SUTURE WAS UNDER TENSION? DEVICE RETURN STATUS. PLEASE DOCUMENT THE SHIPMENT TRACKING NUMBER: PLEASE PROVIDE THE SOURCE OR NAME OF PERSON PROVIDING ANSWERS TO FOLLOW-UP QUESTIONS (NOT THE PERSON RELAYING/SUBMITTING ANSWERS TO LOC OR CHU). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. EVENTS REPORTED VIA: 2210968-2023-04247.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC UROLOGICAL PROCEDURE ON 05/16/2023 AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, WHEN APPLYING THE LAPRATY TO THE SUTURE SOME WILL CLIP, SOME WON¿T CLIP, AND SOME WILL CLIP THEN UNCLIP THEMSELVES. TYPE OF SUTURE BEING USED DURING THE PROCEDURE IS UNKNOWN. SURGEON WORKED THROUGH THE CASE USING THE SAME CLIP APPLIER AND MULTIPLE CLIPS TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ONE DEVICE WILL BE RETURNED. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482647 LAPRA-TY ABSORBABLE X6::SUTURE CLIP CLIP, IMPLANTABLE FZP ETHICON INC. XC200 RJ2ADM 10705031206885

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown