BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAPRA-TY ABSORBABLE X6::SUTURE CLIP

    MDR report key: 15935743 · Received December 7, 2022

    Report

    Report Number
    2210968-2022-10097
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    November 7, 2022
    Report Date
    December 7, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    FZP
    UDI-DI
    20705031206882
    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). 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. WHY WAS PROCEDURE CONVERTED TO AN OPEN? WAS THE PROCEDURE CONVERTED BECAUSE THE CLIPS WOULD NOT APPLY TO THE SUTURE? IF YES, PLEASE PROVIDE DETAILS AS TO WHY AN OPEN PROCEDURE WAS REQUIRED WERE THERE ANY ADVERSE PATIENT CONSEQUENCES RELATED TO THE SUTURE CLIPS NOT APPLYING TO THE SUTURE? LOT NUMBER? HOW MANY SUTURE CLIPS DID NOT APPLY TO THE SUTURE? A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLES REVEALED THAT XC200 RELOAD (A) WAS RECEIVED OPENED WITH NO APPARENT DAMAGE AND WITH 6 CLIPS LOADED. THE RELOAD WAS TESTED FOR FUNCTIONALITY WITH THE TEST DEVICE. UPON FUNCTIONAL TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED, AND DEPLOYED 6 CLIPS AS EXPECTED. THE CLIPS WERE AS INTENDED AND CONFORMS TO OUR MANUFACTURING REQUIREMENTS. AS PART OF QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE CLIP PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE. ANALYSIS: THE PRODUCT WAS RETURNED TO FOR EVALUATION. VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLES REVEALED THAT XC200 RELOAD (B) WAS RECEIVED STERILE WITH NO APPARENT DAMAGE AND WITH 6 CLIPS LOADED. THE RELOAD WAS TESTED FOR FUNCTIONALITY WITH THE TEST DEVICE. UPON FUNCTIONAL TESTING OF THE DEVICE, THE INSTRUMENT LOADED, RETAINED, AND DEPLOYED 6 CLIPS AS EXPECTED. THE CLIPS WERE AS INTENDED AND CONFORMS TO OUR MANUFACTURING REQUIREMENTS. AS PART OF QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE CLIP PERFORMED WITHOUT ANY DIFFICULTIES NOTED. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST MARKET SURVEILLANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A ROBOTIC UROLOGY PROCEDURE ON (B)(6) 2022 AND SUTURE CLIPS WERE USED. DURING THE PROCEDURE, THE SCRUB TECH WAS APPLYING THE CLIP TO 2.0 VICRYL ON THE BACK TABLE THAT THE CLIP WOULD LOAD BUT WOULD POP OFF WHEN ATTEMPTING TO APPLY TO THE SUTURE. SCRUB TECH KEPT ATTEMPTING UNTIL SHE WAS ABLE TO GET ONE TO WORK. CASE WAS CONVERTED TO OPEN DUE TO ISSUES NOT RELATED TO THE DEVICE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308531 LAPRA-TY ABSORBABLE X6::SUTURE CLIP CLIP, IMPLANTABLE FZP ETHICON INC. XC200 SG2AEB 20705031206882

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown