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	01/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a procedure using capsure fixation device, two fasteners were deployed in a row.It was reported that two fasteners got fixated successfully and the loose fasteners were removed from patient's body.The fixation was applied into a hard structure/bone/cooper¿s ligament also the surgeon has performed dry fire to check if the problem re-occurred.Another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, during a procedure using capsure fixation device, two fasteners were deployed in a row while fixating into a hard structure/bone/cooper¿s ligament.The sample is being returned for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for successful fastener delivery.The precautions section of ifu states, " insertion of fasteners into some collagenous structures such as ligaments and tendons is possible but is not possible directly into bone or cartilage.This may damage the device".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 a procedure using capsure fixation device, two fasteners were deployed in a row.It was reported that two fasteners got fixated successfully and the loose fasteners were removed from patient's body.The fixation was applied into a hard structure/bone/cooper¿s ligament also the surgeon has performed dry fire to check if the problem re-occurred.Another device was used to complete the procedure.There was no patient injury.
Additional Manufacturer Narrative
As reported, during a procedure using capsure fixation device, two fasteners were deployed in a row while fixating into a hard structure/bone/cooper¿s ligament.The sample is being returned for evaluation; however, at this time it has not been received.Based on the information available and without having the sample to evaluate, no conclusions can be made.A review of the manufacturing records was performed and found that the lot was manufactured to the specification.The instructions-for-use (ifu) supplied with the device adequately describe the proper technique for successful fastener delivery.The precautions section of ifu states, " insertion of fasteners into some collagenous structures such as ligaments and tendons is possible but is not possible directly into bone or cartilage.This may damage the device".Addendum: this is an addendum to the initial mdr submitted to document the sample evaluation results.The evaluation of the returned sample could not reproduce the reported event that the device deployed two fasteners at once.The device functioned as intended during functional use testing, deploying the last remaining fasteners with no issues.No manufacturing anomalies found.Updated fields: b4, 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.

• 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: 24446080
• Report Number: 1213643-2026-00217
• Device Sequence Number: 21423798
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989(11)250512(17)270428(10)HUKS0500
• 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: 2026
• 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): 03/02/2026

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 Catalogue Number: 0113215
• Device Lot Number: HUKS0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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