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

Catalog Number	0113215
Medical Device Problem Code	Unintended Ejection (1234)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during tapp procedure, when the surgeon was trying to fixate in the patient's abdomen when two fasteners deployed during the third attempt were not fixated and were fired in vitro.The procedure was completed with a new device.There was no patient injury.
Additional Manufacturer Narrative
As reported, the capsure device fired two fasteners during the third attempt.The subject device is said to be available however, at this time has not been returned.Based on the information provided and without having the sample to evaluate, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.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, the capsure device fired two fasteners during the third attempt.The subject device is said to be available however, at this time has not been returned.Based on the information provided and without having the sample to evaluate, no conclusion can be made.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the photo evaluation results and to update the lot number.The photo provided confirms a capsure fastener has been deployed into the peek cap of another fastener, in-vivo.Review of the photo confirms 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 conclusion can be made.Updated fields: b4, d4 (corporate lot no, expiry date, udi no.), g3, g6, h2, h4, 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 tapp procedure, when the surgeon was trying to fixate in the patient's abdomen when two fasteners deployed during the third attempt were not fixated and were fired in vitro.The procedure was completed with a new 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: 22576039
• Report Number: 1213643-2025-00675
• Device Sequence Number: 9700395
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989(11)240927(17)260828(10)HUJW1649
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

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: 08/28/2026
• Device Catalogue Number: 0113215
• Device Lot Number: HUJW1649
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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