MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LYNX ULTRA SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET

Model Number	M0068503060
Medical Device Problem Codes	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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.
Event or Problem Description
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.

• Brand Name: LYNX ULTRA SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 22966920
• Report Number: 2124215-2025-62123
• Device Sequence Number: 9151543
• Product Code: OTN
• UDI-Device Identifier: 00191506007676
• UDI-Public: (01)00191506007676(17)280303(10)35986360
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K211223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0068503060
• Device Catalogue Number: M0068503060
• Device Lot Number: 0035986360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 10/13/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/03/2025; 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown