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

Catalog Number	0113230
Medical Device Problem Codes	Unintended Ejection (1234); Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a transabdominal preperitoneal hernia repair of groin hernia, capsure fixation device deployed the fasteners which did not fixate into the mesh and tissues fully.It was reported that some of the fasteners were deployed two fasteners at a time.The reported problem occurred after third fire in which first 3 fasteners were fired good.It was reported that partially fixated fastener and some deployed connected fasteners were removed from the patient's body.It was reported that another product was used to complete the procedure and there was delay in surgery time and anesthesia.There was no reported injury.
Additional Manufacturer Narrative
As reported, capsure did not fixate, and deployed fasteners connected between each other.Based on videos review, there are several fixated fasteners present in the video, one of the fasteners appears to have not fixated fully into the mesh, another fastener has a second fastener deployed into the peek cap.It was also seen in the videos that the surgeon was attempting to fixate the mesh with the device and a fastener does deploy but appears to not fixate the mesh.Based on the information provided and without having the sample to evaluate, no conclusions can be made.A review of manufacturing records was performed and found that the device was manufactured 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.

• 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: 21507155
• Report Number: 1213643-2025-00075
• Device Sequence Number: 4590863
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996(17)260228(10)HUJQ0774
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2025

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: 02/28/2026
• Device Catalogue Number: 0113230
• Device Lot Number: HUJQ0774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Initial Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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