MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAPIO SLIM; INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, TRANSVAGINAL REPAIR OF PELVIC OR

Model Number	M0068318260
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Capio device noted by surgeon to be misfiring.No further description found in operative note.Manufacturer response for instrumentation, surgical mesh, urogynecologic, transvaginal repair of pelvic or, capio slim (per site reporter).Not known at this time.

• Brand Name: CAPIO SLIM
• Common Device Name: INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, TRANSVAGINAL REPAIR OF PELVIC OR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 25374125
• Report Number: 25374125
• Device Sequence Number: 9204403
• Product Code: PWI
• UDI-Device Identifier: 08714729842804
• UDI-Public: (01)08714729842804
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/26/2026
• Report Date (Section F): 05/26/2026

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: M0068318260
• Device Catalogue Number: M0068318260
• Device Lot Number: 37991514
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/03/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 05/26/2026