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

Catalog Number	0113215
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, when fixating the mesh with a capsure fixation device, the peek part of a fastener detached, and the steel part fixated the mesh.During sample evaluation the device functioned as intended during simulated use testing.No other peek caps were found to detach in testing.No manufacturing anomalies found.Based on the sample evaluation the reported event of the fastener peek cap detaching from the fastener coil is likely the result of an event occurring during user/device interface with forces applied while in use.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.The ifu states: "carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as bone, nerves, vessels, and viscera.Use of the capsure permanent fixation system in the close vicinity of such underlying structures is contraindicated" 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 laparoscopic inguinal hernia repair procedure, the capsure fixation device was used to fixate the 3dmax light mesh.When fixating the mesh, the peek part of a fastener detached, and the steel part fixated the mesh.It was reported that the fixation was not applied in the hard structure.There was no patient injury.
Additional Manufacturer Narrative
As reported, when fixating the mesh with a capsure fixation device, the peek part of a fastener detached, and the steel part fixated the mesh.During sample evaluation the device functioned as intended during simulated use testing.No other peek caps were found to detach in testing.No manufacturing anomalies found.Based on the sample evaluation the reported event of the fastener peek cap detaching from the fastener coil is likely the result of an event occurring during user/device interface with forces applied while in use.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.The ifu states: "carefully inspect the area in the vicinity of the tissue being fastened to avoid inadvertent penetration of underlying structures such as bone, nerves, vessels, and viscera.Use of the capsure permanent fixation system in the close vicinity of such underlying structures is contraindicated" 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." addendum: h11: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to correct the annex c code.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 laparoscopic inguinal hernia repair procedure, the capsure fixation device was used to fixate the 3dmax light mesh.When fixating the mesh, the peek part of a fastener detached, and the steel part fixated the mesh.It was reported that, the fixation was not applied in the hard structure.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: 22350628
• Report Number: 1213643-2025-00540
• Device Sequence Number: 14658983
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989(11)240806(17)260728(10)HUJV0167
• 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,Followup
• Report Date (Section B): 07/01/2025

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: 0113215
• Device Lot Number: HUJV0167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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