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	05/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during the laparoscopic incisional hernia (ipom-plus) repair procedure using ventralight st mesh, the capsure device was unable to secure the mesh properly and after fasteners were inserted, there were three consecutive cases where the fasteners did not come out of the shaft properly and came off the mesh.It was reported that another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the capsure straight fasteners did not fixate the mesh.There was no reported patient injury.The subject device was returned for evaluation; however, at this time evaluation is not yet completed.When sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records confirms product was made to specification.Note, the manufacturing date (15-feb-2024) is considered to be a best estimate.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 the laparoscopic incisional hernia (ipom-plus) repair procedure using ventralight st mesh, the capsure device was unable to secure the mesh properly and after fasteners were inserted, there were three consecutive cases where the fasteners did not come out of the shaft properly and came off the mesh.It was reported that another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, the capsure straight fasteners did not fixate the mesh.There was no reported patient injury.The subject device was returned for evaluation; however, at this time evaluation is not yet completed.When sample evaluation is completed, a supplemental emdr will be submitted.Review of manufacturing records confirms product was made to specification.Addendum: this supplemental mdr is submitted to document the sample evaluation results.Based on the reported condition and sample evaluation findings, the issue regarding the device's alleged failure to fire could not be replicated.A definitive root cause as to why the cannula was misaligned or failure to fixate could not be determined at this moment as is not representative of the device during the manufacturing process.Per review, it was identified that the capsure manufacturing process contains controls in place that are capable of detecting discrepancies regarding the product¿s device assembly.Training evidence of the manufacturing personnel executing operations evaluated were requested and found in compliance with training requirements.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for fastener delivery.Updated fields: b4, d9, g3, g6, h2, h6, h10.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: 22175691
• Report Number: 1213643-2025-00457
• Device Sequence Number: 20790885
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996(17)260128(10)HUJP1200
• 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,Followup
• Report Date (Section B): 06/11/2025

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: 01/28/2026
• Device Catalogue Number: 0113230
• Device Lot Number: HUJP1200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• 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