MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 CAPSURE; STAPLE, IMPLANTABLE

Catalog Number	0113215
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, on (b)(6) 2026 during a tapp procedure using capsure straight fixation device, no resistance was felt during the first fastener deployment, causing the fasteners to slip out.The device functioned normally after the first fire.Reportedly, procedure was completed using the same device without any further complication.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, during a tapp procedure using capsure straight fixation device, no resistance was felt during the first fastener deployment, causing the fasteners to slip out.The same device was used to complete the case with no further issue.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records confirms product was manufactured to specification.The instructions-for-use supplied with the device adequately describe the proper technique for fastener delivery.The ifu states "compress hand piece trigger in a single, complete and uninterrupted stroke to drive a permanent fastener through the mesh into the tissue.Keep consistent counter pressure on the tip of the device through the entire stroke.Release the trigger allowing it to return completely to its resting position.Repeat this procedure until all required fasteners are deployed." note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: CAPSURE
• Common Device Name: STAPLE, IMPLANTABLE
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 25613904
• Report Number: 1213643-2026-00793
• Device Sequence Number: 10217531
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989(11)250909(17)270828(10)HUKV0761
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2026

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 Catalogue Number: 0113215
• Device Lot Number: HUKV0761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown