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	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the capsure fixation device fasteners could not fixate the mesh.Evaluation of the returned sample could not reproduce the reported event.The device functioned as intended during functional and simulated use testing, deploying the last remaining fasteners with no issues.There is no indication the device would not fixate as the device was also used to finish the procedure with no further issue.The most probable cause is an event occurring user device interface.No manufacturing anomalies found.Review of manufacturing records shows product was made to specification.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.The precaution section of ifu states, ¿use caution when applying the capsure fastener over or in proximity to underlying bone, vessels, nerves, or viscera" and "care should be taken not to use excessive counter pressure as this may damage the tissue, the material being fixated, and/or the device".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 tapp technique the capsure fixation device was used to fixate the 3dmax mesh.However, the deployed fasteners could not fixate the mesh.It was noted that following fixation to cooper¿s ligament, the impact felt unusual.Subsequently, an attempt was made to fixate the mesh to soft tissue, but this was unsuccessful, and a fastener fell into the abdominal cavity.The fallen fastener was retrieved, and the procedure was completed using the same device.There was no reported 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: 22875945
• Report Number: 1213643-2025-00787
• Device Sequence Number: 12184883
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989(11)241223(17)261128(10)HUJZ0960
• 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: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/05/2025

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 Catalogue Number: 0113215
• Device Lot Number: HUJZ0960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Initial Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• 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