BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LYNX ULTRA SYSTEM

    MDR report key: 22966920 · Received September 4, 2025

    Report

    Report Number
    2124215-2025-62123
    Event Type
    Malfunction
    Date Received
    September 4, 2025
    Date of Event
    August 19, 2025
    Report Date
    November 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    00191506007676
    PMA / PMN Number
    K211223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H11: UPON RECEIPT AT OUR QUALITY ASSURANCE LABORATORY, THIS CAPIO DEVICE UNDERWENT A THOROUGH ANALYSIS. VISUAL INSPECTION OF THE DEVICE REVEALED A DAMAGED MESH WHEREIN PARTS OF THE MESH WHERE OUTSIDE THE SLEEVE, CONFIRMING THE EVENT OF MESH DAMAGED/DEFECTIVE. BASED ON THE INFORMATION AVAILABLE AND THE ANALYSIS RESULTS, THE REPORTED ALLEGATION OF THE MESH BEING DAMAGED/DEFECTIVE WAS CONFIRMED THROUGH PRODUCT ANALYSIS. THE CONDITION IN WHICH THE DEVICE WAS RECEIVED REVEALED THAT DIFFICULTY WAS ENCOUNTERED DURING PLACEMENT, AS THE DOCTOR HAD TO REPOSITION THE TROCARS MULTIPLE TIMES. SINCE THE ADVERSE EVENT OCCURRED DURING THE PROCEDURE AND THE DEVICE HAD NO INFLUENCE ON THE EVENT, A CONCLUSION CODE OF "ADVERSE EVENT RELATED TO PROCEDURE" WAS ASSIGNED TO THIS INVESTIGATION, AS MULTIPLE REPOSITIONS LED TO THE MESH BECOMING DAMAGED AND PART OF IT BEING OBSERVED OUTSIDE THE SLEEVE. BLOCK G4: THE LYNX ULTRA SYSTEM DEVICE RECEIVED FDA CLEARANCE THROUGH TWO SEPARATE 510(K) APPROVALS: K211223 AND K231549. BLOCK H6: DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DIFFICULT TO ADVANCE.

    Additional Manufacturer Narrative · 0

    BLOCK G4: THE LYNX ULTRA SYSTEM DEVICE RECEIVED FDA CLEARANCE THROUGH TWO SEPARATE 510(K) APPROVALS: K211223 AND K231549. BLOCK H6: DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DIFFICULT TO ADVANCE.

    Additional Manufacturer Narrative · 0

    BLOCK H11: BLOCK B5 HAS BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON SEPTEMBER 9, 2025. BLOCK G4: THE LYNX ULTRA SYSTEM DEVICE RECEIVED FDA CLEARANCE THROUGH TWO SEPARATE 510(K) APPROVALS: K211223 AND K231549. BLOCK H6: DEVICE CODE A150205 CAPTURES THE REPORTABLE EVENT OF DIFFICULT TO ADVANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE USING A LYNX ULTRA SYSTEM DEVICE, THE PHYSICIAN ENCOUNTERED DIFFICULTY WITH TROCAR PLACEMENT. THE RIGHT TROCAR APPEARED TO BE POSITIONED TOO CLOSE TO THE BLADDER, REQUIRING THE PHYSICIAN TO REPOSITION THE TROCARS MULTIPLE TIMES. AS A RESULT, THE MESH BECAME DISTORTED. DISSECTION WAS PARTICULARLY DIFFICULT FOR THE PATIENT, WHICH THE PHYSICIAN BELIEVES WAS A CONTRIBUTING FACTOR TO THE DIFFICULTY EXPERIENCED, ALTHOUGH THE PATIENT'S ANATOMY WAS UNREMARKABLE. A SECOND LYNX ULTRA SYSTEM DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE USING A LYNX ULTRA SYSTEM DEVICE, THE PHYSICIAN ENCOUNTERED DIFFICULTY WITH TROCAR PLACEMENT. THE RIGHT TROCAR APPEARED TO BE POSITIONED TOO CLOSE TO THE BLADDER, REQUIRING THE PHYSICIAN TO REPOSITION THE TROCARS MULTIPLE TIMES. AS A RESULT, THE MESH BECAME DISTORTED. DISSECTION WAS PARTICULARLY DIFFICULT FOR THE PATIENT, WHICH THE PHYSICIAN BELIEVES WAS A CONTRIBUTING FACTOR TO THE DIFFICULTY EXPERIENCED. A SECOND LYNX ULTRA SYSTEM DEVICE WAS USED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE USING A LYNX ULTRA SYSTEM DEVICE, THE PHYSICIAN ENCOUNTERED DIFFICULTY WITH TROCAR PLACEMENT. THE RIGHT TROCAR APPEARED TO BE POSITIONED TOO CLOSE TO THE BLADDER, REQUIRING THE PHYSICIAN TO REPOSITION THE TROCARS MULTIPLE TIMES. AS A RESULT, THE MESH BECAME DISTORTED. DISSECTION WAS PARTICULARLY DIFFICULT FOR THE PATIENT, WHICH THE PHYSICIAN BELIEVES WAS A CONTRIBUTING FACTOR TO THE DIFFICULTY EXPERIENCED, ALTHOUGH THE PATIENT'S ANATOMY WAS UNREMARKABLE. A SECOND LYNX ULTRA SYSTEM DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018590 LYNX ULTRA SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET OTN BOSTON SCIENTIFIC CORPORATION M0068503060 0035986360 00191506007676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown