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	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic abdominal wall incisional hernia repair procedure a capsure fixation device used to fixate an unknown mesh.It was reported that the fastener got caught on the mesh from the first attempt and the tip of the shaft could not be removed.It was also reported that the loose fasteners were removed from the patient's body, and the procedure was completed using another device.There was no patient injury.
Additional Manufacturer Narrative
As reported, the capsure fasteners failed to fixate the mesh.Evaluation of the returned sample could not reproduce the reported event that the device failed to fixate.Functional and simulated use testing found the device to function as intended deploying the remaining fasteners with no issues.No manufacturing anomalies found.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only complaint for the reported lot of 495 units.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: 22748751
• Report Number: 1213643-2025-00742
• Device Sequence Number: 8607113
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996(11)240809(17)260728(10)HUJV0672
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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 Expiration Date: 07/28/2026
• Device Catalogue Number: 0113230
• Device Lot Number: HUJV0672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown