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

Catalog Number	0113315
Medical Device Problem Code	Failure to Form Staple (2579)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, the optifix at fixation device ejected fasteners sporadically.The subject device was returned for evaluation.The device was found to misfire during the initial functional evaluation.Internal components evaluation found all the inner components are in place and no damage was found.The sample evaluation is ongoing at this time, as such no conclusion can be made.A supplemental mdr will be submitted, to document the results of the sample evaluation once completed.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.The instructions-for-use (ifu) for the optifix at fixation device prescribes the proper method for use of this device for proper fastener delivery and includes "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." this mdr represents the bard/davol optifix at (device #1).An additional mdr was submitted to represent the bard/davol optifix at (device #2).
Event or Problem Description
As reported, during a procedure on (b)(6) 2022, the bard/davol optifix at fixation device (device #1) misfired several times and fasteners were released sporadically.As reported, the device was not used and a second optifix at (device #2) was opened, and the same issue recurred.As reported, all fasteners were removed from the patient's body and there was a procedural delay in completing the case.There was no reported patient injury.Note, this file represents device #1.
Additional Manufacturer Narrative
As reported, the optifix at fixation device ejected fasteners sporadically.The subject device was returned for evaluation.The device was found to misfire during the initial functional evaluation.Internal components evaluation found all the inner components are in place and no damage was found.The sample evaluation is ongoing at this time, as such no conclusion can be made.A supplemental mdr will be submitted, to document the results of the sample evaluation once completed.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.The instructions-for-use (ifu) for the optifix at fixation device prescribes the proper method for use of this device for proper fastener delivery and includes "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." addendum: this supplemental mdr is submitted to report the sample evaluation results.Evaluation of the sample finds that the device misfired potentially due to an incorrect feed assembly setback.The cause for the incorrect feed assembly setback is deemed unknown since the discrepancy could not be replicated with the unit received.Based on the sample evaluation and investigation performed, a definitive root cause for reported event cannot be determined.This semdr represents the bard/davol optifix at (device #1).An additional semdr was submitted to represent the bard/davol optifix at (device #2).Sample evaluated.
Event or Problem Description
As reported, during a procedure on (b)(6) 2022 the bard/davol optifix at fixation device (device #1) misfired several times and fasteners were released sporadically.As reported, the device was not used and a second optifix at (device #2) was opened, and the same issue recurred.As reported, all fasteners were removed from the patient's body and there was a procedural delay in completing the case.There was no reported patient injury.Note, this file represents device #1.

• 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: 14015048
• Report Number: 1213643-2022-00136
• Device Sequence Number: 20408399
• Product Code: GDW
• UDI-Device Identifier: 00801741136559
• UDI-Public: (01)00801741136559
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022

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: 06/28/2023
• Device Catalogue Number: 0113315
• Device Lot Number: HUFU0421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2021
• 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