BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPRA-TY ABSORBABLE X6::SUTURE CLIP

    MDR report key: 21874521 · Received April 21, 2025

    Report

    Report Number
    2210968-2025-04308
    Event Type
    Malfunction
    Date Received
    April 21, 2025
    Date of Event
    January 1, 2025
    Report Date
    April 21, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    FZP
    UDI-DI
    10705031206885
    PMA / PMN Number
    K931492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: * WERE THERE ANY PATIENT CONSEQUENCE? UNKNOWN. * CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT USED? YES, 100ML4. *PLEASE CONFIRM IF THERE IS AN ISSUE WITH THE APPLIER? YES, THE SALES REP THINKS THERE COULD OF BEEN BASED ON THE DESCRIPTION, THEY TRIED TWO DIFFERENT APPLIERS BUT THEY COULD NOT GET THEM TO SNAP TOGETHER. THEY PROBABLY TRIED TEN DIFFERENT LAPRA-TYS. AND THEY WOULD EITHER IMMEDIATELY SPRING OPEN OR NEVER SNAP TOGETHER. * WHAT SUTURE TYPE AND SIZE WAS USED? THE SALES REP WAS TOLD IT WAS A 2-0 VICRYL. EXACT PRODUCT CODE IS UNKNOWN. * WHEN THE EVENT OCCURRED, WAS THE SUTURE PLACED NEAR THE HINGE OF THE CLIP? UNKNOWN * 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? UNKNOWN * WAS THE APPLIER CHECKED FOR DAMAGED (JAWS STRAIGHT AND ALIGNED)? UNKNOWN * PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) (B)(6) THE SALES REP ALSO STATED THAT THREE DIFFERENT PEOPLE TRIED TO USE THE APPLIER AND IT DID NOT WORK. ALL INFORMATION AVAILABLE HAS BEEN PROVIDED ABOVE. * WERE THERE ANY PATIENT CONSEQUENCES? NOT THAT WE ARE AWARE OF. * CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT USED? L100ML4. * PLEASE CONFIRM IF THERE IS AN ISSUE WITH THE APPLIER? THE TEAM DID OPEN AN ADDITIONAL INSTRUMENT TO TRY BUT HAD THE SAME ISSUE. BOTH WERE FLAGGED FOR CS TO INSPECT FURTHER. * WHAT SUTURE TYPE AND SIZE WAS USED? VICRYL 2-0. * 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? NOT THEY WERE NOT THEY KEPT POPPING BACK OPEN EVEN WHEN THEY WERE MANUALLY CLOSED WITHOUT ANY SUTURE * WAS THE APPLIER CHECKED FOR DAMAGED (JAWS STRAIGHT AND ALIGNED)? NO DAMAGE REPORTED FROM CS. * PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) (PLEASE REFER THE ATTACHED EMAIL).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2025 AND SUTURECLIPS WERE USED. DURING THE PROCEDURE, IT WAS REPORTED BY THE SALES REP THAT THEY TRIED TWO DIFFERENT APPLIERS BUT THEY COULD NOT GET THEM TO SNAP TOGETHER. THEY PROBABLY TRIED TEN DIFFERENT LAPRA-TYS. AND THEY WOULD EITHER IMMEDIATELY SPRING OPEN OR NEVER SNAP TOGETHER. DEVICE AVAILABILITY UNKNOWN. THERE WERE NO ADVERSE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015920 LAPRA-TY ABSORBABLE X6::SUTURE CLIP CLIP, IMPLANTABLE FZP ETHICON INC. 10705031206885

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown