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

Catalog Number	0113215
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a laparoscopic inguinal hernia repair, capsure fixation device failed to fixate.Three fasteners which were released from the device were difficult to insert and did not penetrate the tissue deeply, leaving a gap between the mesh and abdominal wall.It was reported that the three fasteners that did not penetrate completely were left in the patient's body.Another capsure device was then used allowing the procedure to finish without any issues.There was no patient injury.
Additional Manufacturer Narrative
As reported, during a laparoscopic inguinal hernia repair using the capsure fixation device, the fasteners did not penetrate deeply.The sample is said to be returned for evaluation but has not yet been received.Based on the information provided and not having the physical sample to evaluate, no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the evaluation results.Review of manufacturing records confirms product was manufactured 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.
Additional Manufacturer Narrative
As reported, during a laparoscopic inguinal hernia repair using the capsure fixation device, the fasteners did not penetrate deeply.The sample is said to be returned for evaluation but has not yet been received.Based on the information provided and not having the physical sample to evaluate, no conclusions can be made.If/when the sample is returned and evaluated a supplemental mdr will be submitted to document the evaluation results.Review of manufacturing records confirms product was manufactured to specification.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the sample evaluation results.The evaluation of the returned sample could not reproduce the reported event.The device functioned as intended during functional and simulated use testing, deploying the last remaining fasteners with no issues.No manufacturing anomalies were 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.
Event or Problem Description
As reported, during a laparoscopic inguinal hernia repair, capsure fixation device failed to fixate.Three fasteners which were released from the device were difficult to insert and did not penetrate the tissue deeply, leaving a gap between the mesh and abdominal wall.It was reported that the three fasteners that did not penetrate completely were left in the patient's body.Another capsure device was then used allowing the procedure to finish without any issues.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: 23877558
• Report Number: 1213643-2025-01251
• Device Sequence Number: 14645280
• Product Code: GDW
• UDI-Device Identifier: 00801741094989
• UDI-Public: (01)00801741094989(11)250303(17)270228(10)HUKP1483
• 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,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2025

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 Catalogue Number: 0113215
• Device Lot Number: HUKP1483
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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