BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPRA-TY ABSORBABLE X6::SUTURE CLIP

    MDR report key: 17877268 · Received October 5, 2023

    Report

    Report Number
    2210968-2023-07419
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 7, 2023
    Report Date
    November 6, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    FZP
    UDI-DI
    10705031206885
    PMA / PMN Number
    K931492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/6/2023. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: PLEASE CONFIRM THE NUMBER OF CLIPS THAT "WOULD NOT CLOSE" DURING THIS PROCEDURE. 7 CLIPS PACKAGE LOT NUMBER OF THE CLIPS? TE2AMA PLEASE PROVIDE THE APPLIER PRODUCT CODE AND LOT NUMBER? KA200 LOT# 1802064 AND 1108032 PLEASE CONFIRM IF THERE IS AN ISSUE WITH THE APPLIER? IF YES, PLEASE CREATE A PRODUCT COMPLAINT AND PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). APPLIERS HAVE BEEN CONFIRMED TO BE WORKING CORRECTLY WHAT SUTURE TYPE AND SIZE WAS USED? 3-0 VICRYL 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? WAS THE APPLIER CHECKED FOR DAMAGED (JAWS STRAIGHT AND ALIGNED)? APPLIER HAS BEEN CHECKED IF THE CLIP DID NOT CLOSE/HOLD ON THE SUTURE, WAS THE CLIP USED IN AN APPLICATION WHERE THE SUTURE WAS UNDER TENSION? NO EVENT/PROCEDURE NAME AND DATE? LEFT PARTIAL NEPHRECTOMY (B)(6) 2023. PLEASE PROVIDE THE STATUS OF THE DEVICE(S) AS IT HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE HAS BEEN SHIPPED, PLEASE PROVIDE THE SHIPMENT TRACKING DETAILS. 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. RELATED REPORTS: 2210968-2023-07418, 2210968-2023-08562, 2210968-2023-08565, 2210968-2023-08566, 2210968-2023-08567, & 2210968-2023-08568.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/5/2023. 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. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. 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: PLEASE CONFIRM THE NUMBER OF CLIPS THAT "WOULD NOT CLOSE" DURING THIS PROCEDURE. PACKAGE LOT NUMBER OF THE CLIPS? PLEASE PROVIDE THE APPLIER PRODUCT CODE AND LOT NUMBER? PLEASE CONFIRM IF THERE IS AN ISSUE WITH THE APPLIER? IF YES, PLEASE CREATE A PRODUCT COMPLAINT AND PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). WHAT SUTURE TYPE AND 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 DAMAGED (JAWS STRAIGHT AND ALIGNED)? IF THE CLIP DID NOT CLOSE/HOLD ON THE SUTURE, WAS THE CLIP USED IN AN APPLICATION WHERE THE SUTURE WAS UNDER TENSION? EVENT/PROCEDURE NAME AND DATE? THE FOLLOWING INFORMATION WAS RECEIVED: DEVICE AVAILABLE FROM CUSTOMER. PLEASE NOTE THESE ARE NOT ACTUAL CLIPS FROM PROCEDURE. THOSE WERE DISCARDED. RETURN PRODUCT IS FROM SAME BOX. A DEVICE HAS BEEN RECEIVED, HOWEVER IT HAS NOT YET BEEN EVALUATED. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM RELATED REPORTS: 2210968-2023-07418.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE CLIPS WERE USED. THE CLIPS WOULD NOT CLOSE. NO PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352784 LAPRA-TY ABSORBABLE X6::SUTURE CLIP CLIP, IMPLANTABLE FZP ETHICON INC. TE2AMA 10705031206885

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown