MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO; SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC SURGICAL MESH

Model Number	M0068311251
Medical Device Problem Code	Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a050502 captures the reportable event of device misfire.
Event or Problem Description
It was reported that during a procedure performed using a capio slim device, the device misfired.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: device code a050502 captures the reportable event of device misfired.Block h11: the device was not returned; therefore, no physical or visual examination could be performed, and the reported event of device misfired could not be confirmed due to the lack of objective evidence.A review of the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.A review was completed and confirmed that the event of device misfired was defined in the risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.Based on the information available, the most probable cause of the reported issue could not be determined due to insufficient evidence.In the absence of device return, device evaluation, or additional objective evidence, the most probable causes remain unknown.Therefore, this complaint is concluded with an investigation conclusion code of "unable to exclude device problem," as the investigation does not provide sufficient evidence to confirm or rule out the reported device malfunction.
Event or Problem Description
It was reported that during a procedure performed using a capio slim device, the device misfired.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: CAPIO
• Common Device Name: SPECIALIZED SURGICAL INSTRUMENTATION FOR USE WITH UROGYNECOLOGIC SURGICAL MESH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24483077
• Report Number: 2124215-2026-11331
• Device Sequence Number: 16106420
• Product Code: PWI
• UDI-Device Identifier: 08714729257615
• UDI-Public: (01)08714729257615(17)271204(10)35420908
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K172060
• 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): 06/04/2026

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: M0068311251
• Device Catalogue Number: 831-125
• Device Lot Number: 0035420908
• 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: 02/06/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 05/15/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/09/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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