MAUDE Adverse Event Report: Davol Inc., Sub. C.R. Bard, Inc. -1213643 Optifix Straight; Staple, implantable

Catalog Number	0113127
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
As reported on 28-jul-2026, during a laparoscopic left inguinal hernia repair halfway through the use of the optifix fixation device, it did not "fully tack the mesh down, when the resident was attempting to use it." "the surgeon took over and after a few more failed attempts, when pulling the trigger, there was a jam and it did not release anything." the procedure was completed with another device.There was no patient harm or injury.
Additional Manufacturer Narrative
As reported, during a laparoscopic left inguinal hernia repair halfway through the use of the optifix fixation device, it did not "fully tack the mesh down.The procedure was completed with another device.There was no patient harm or injury.Evaluation of the samples finds for bent guide wire and damaged backup tabs.The reported deployment issues are a known result of bent guide wire and damaged backup tabs.The components are found to be bent from applied forces while in use.No manufacturing anomies were found.A review of manufacturing records was performed and found that the device was manufactured to specification.The instructions-for-use supplied with the device adequately describes the proper technique for fastener delivery.The precautions section states "care should be taken not to use excessive counterpressure as this may damage the distal tip of the device as well as the mesh and/or tissue." 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: Optifix Straight
• 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 ; +1(800)556-6756
• MDR Report Key: 50346384
• Report Number: 1213643-2026-01069
• Device Sequence Number: 18700249
• Product Code: GDW
• UDI-Device Identifier: 00801741074325
• UDI-Public: (01)00801741074325(17)261028(10)HUJY0958
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142873
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2026

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: 0113127
• Device Lot Number: HUJY0958
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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