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

Catalog Number	0113230
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, capsure fixation device deployed three consecutive shots during use.The user was able to sue the same device to complete the procedure with no further issues.Based on photo review, there does not appear to be any damage to the cannula or housing.The subject device was not returned for evaluation.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records shows product was made to specification.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 inguinal hernia repair, the surgeon tried to fixate the 3dmax light mesh using capsure fixation device.It was reported that device deployed three fasteners in tandem on one attempt which were found to be deployed into one another.As reported, this issue occurred once during use of the 30-fastener device.The 3 tandem fasteners failed to fixate the mesh, and the device was not used in hard structure.The procedure was completed with same device.There was no reported patient injury.
Additional Manufacturer Narrative
As reported, capsure fixation device deployed three consecutive shots during use.The user was able to use the same device to complete the procedure with no further issues.Based on photo review, there does not appear to be any damage to the cannula or housing.The subject device was not returned for evaluation.Based on the information available and without having the sample to evaluate, no conclusions can be made.Review of manufacturing records shows product was made to specification.Addendum: this supplemental mdr is submitted to document the sample evaluation results.The evaluation of the device could not reproduce the reported event that the device deployed two fasteners at once during fixation.The device functioned as intended during functional and simulated use testing with deploying 22 remaining fasteners without any issue.No manufacturing anomalies found.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 inguinal hernia repair, the surgeon tried to fixate the 3dmax light mesh using capsure fixation device.It was reported that device deployed three fasteners in tandem on one attempt which were found to be deployed into one another.As reported, this issue occurred once during use of the 30-fastener device.The 3 tandem fasteners failed to fixate the mesh, and the device was not used in hard structure.The procedure was completed with 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: 21526758
• Report Number: 1213643-2025-00079
• Device Sequence Number: 18531861
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996(17)260128(10)HUJP1200
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/12/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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