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

Catalog Number	0113230
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the capsure fixation fasteners failed to penetrate the mesh.The subject device is being returned for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of manufacturing records was conducted and shows the product was manufactured to specification.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.
Event or Problem Description
As reported, during a tapp procedure on (b)(6) 2026, when using the capsure fixation device the first fastener failed to penetrate the mesh into fascia.It was reported that 8 fasteners were fired around the circumference, but none of them were fully fixated and became loose when the mesh was slightly pulled.Another capsure device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, the capsure fixation fasteners failed to penetrate the mesh.The subject device is being returned for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of manufacturing records was conducted and shows the product was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.The evaluation of the subject device and returned same lot devices did not reproduce the reported event of failed to fixate.All devices functioned as intended during functional and simulated use testing.No manufacturing anomalies were found.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.
Event or Problem Description
As reported, during a tapp procedure on (b)(6) 2026, when using the capsure fixation device the first fastener failed to penetrate the mesh into fascia.It was reported that 8 fasteners were fired around the circumference, but none of them were fully fixated and became loose when the mesh was slightly pulled.Another capsure device was used to complete the procedure.There was no patient injury.

• 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: 24388318
• Report Number: 1213643-2026-00184
• Device Sequence Number: 13326356
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996(11)250303(17)270228(10)HUKP1446
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

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: 0113230
• Device Lot Number: HUKP1446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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