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	01/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during ipom plus ventral hernia repair procedure, the capsure fixation device deployed two fasteners at a single fire.It was reported that the issue occurred after fourth fastener and surgeon was not able to remove the two fasteners from patient's body.The surgeon completed the procedure with another device.There was surgical delay, and no patient harm or serious injury occurred.
Additional Manufacturer Narrative
As reported, capsure deployed two fasteners at a single fire.Based on photos provided, there is a second fastener deployed into the peek cap of the fixated fastener.The photos do not assist in determining root cause.Based on the information provided and without having the sample to evaluate, a definitive root cause cannot be determined.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.
Additional Manufacturer Narrative
As reported, capsure deployed two fasteners at a single fire.Based on photos provided, there is a second fastener deployed into the peek cap of the fixated fastener.The photos do not assist in determining root cause.Based on the information provided and without having the sample to evaluate, a definitive root cause cannot be determined.Review of manufacturing records shows product was made to specification.To date, this is the only reported complaint for this manufacturing lot of 445 units.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, deploying the 12 fasteners with no issues.No manufacturing anomalies found.Updated fields: b4, d6.A (medical device implant date), d9, g3, g6, h2, h3, 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.
Event or Problem Description
As reported, during ipom plus ventral hernia repair procedure, the capsure fixation device deployed two fasteners at a single fire.It was reported that the issue occurred after fourth fastener and surgeon was not able to remove the two fasteners from patient's body.The surgeon completed the procedure with another device.There was surgical delay, and no patient harm or serious injury occurred.

• 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: 21265979
• Report Number: 1213643-2025-00027
• Device Sequence Number: 3688701
• Product Code: GDW
• UDI-Device Identifier: 00801741094996
• UDI-Public: (01)00801741094996(11)240606(17)260528(10)HUJS2263
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 02/05/2025

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: 05/28/2026
• Device Catalogue Number: 0113230
• Device Lot Number: HUJS2263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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