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

Catalog Number	0113330
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, during laparoscopic ventral hernia repair using optifix at fasteners failed to fixate the mesh properly.The evaluation of returned sample failed to reproduce the reported event of device failed to fixate.The device functioned as intended during functional and simulated use testing.No manufacturing anomalies were found.Review of manufacturing records confirms the product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units.The instructions-for-use, supplied with this device states, "place the tip of the optifix at absorbable fixation system at the desired location perpendicular to the mesh or tissue and apply adequate counterpressure.Different types of mesh may require different amounts of counterpressure.Adjust angle and counterpressure appropriately." 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 ventral hernia repair on (b)(6) 2026, the surgeon attempted to fixate the mesh using an optifix at fixation device; however, despite several attempts, the fasteners failed to properly secure the mesh.The loose fasteners were removed from the patient and another fixation device to completed the procedure.The surgeon applied counter pressure but was unsuccessful in fixating the mesh.There was no patient harm or injury.

• Brand Name: OPTIFIX AT
• 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: 25162140
• Report Number: 1213643-2026-00627
• Device Sequence Number: 15618701
• Product Code: GDW
• UDI-Device Identifier: 00801741136566
• UDI-Public: (01)00801741136566(17)271028(10)HUKY1098
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K191287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026

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: 0113330
• Device Lot Number: HUKY1098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2026
• 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