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	04/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during a laparoscopic abdominal ipom incisional hernia surgery 10 capsure fasteners did not fixate the mesh/tissue.The subject device was not available for evaluation.However, photos/ video was provided showing fasteners that have fixated successfully, and fasteners that are not fully fixated to the mesh (proud).Photos show the surgeon removing the proud fasteners.The photos and video confirm the reported event, however, do not assist in determining a root cause.Based on the information provided and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) 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.
Event or Problem Description
As reported, during laparoscopic abdominal ipom incisional hernia surgery while using capsure fixation device, nearly 10 fasteners did not fixate the mesh/tissue.Fasteners that were not completely fixated were removed from patient.The procedure was completed using a non-bd device.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: 21985382
• Report Number: 1213643-2025-00368
• Device Sequence Number: 14518948
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996(17)260128(10)HUJP1399
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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: 01/28/2026
• Device Catalogue Number: 0113230
• Device Lot Number: HUJP1399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2024
• 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