MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. VERITAS FOOTPEDAL; UNIT, PHACOFRAGMENTATION

Model Number	VRT680700
Medical Device Problem Codes	Mechanical Problem (1384); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluation: the system was evaluated by a field service engineer (fse).The fse was onsite due to system advancing modes without footpedal (fp) being activated; could not duplicate issue.Service completed veritas performance checklist.Device did not function as intended but no failures were found during evaluation.Service replaced the fp proactively.Veritas meets jnj specifications.Manufacturing record review: the manufacturing records for the device were reviewed.There were no discrepancies or non-conformances experienced during manufacturing.The system and its components met all specifications prior to being released.Conclusion: the device did not function as intended but no failures were found during evaluation.Service replaced the fp proactively.Veritas meets jnj specifications.As a result of the time of investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision , inc has been sumitted.
Event or Problem Description
The account reported system advanced modes without the surgeon activating foot switch.The surgeon was operating and was in the epi setting when the machine advanced to the ia cortex mode without him activating it manually with the foot switch.It happened multiple times but only once did he have patient injury resulting in a vitrectomy.No additional information was received.This report is for the footpedal.A separate report will be submitted for the veritas console.
Additional Manufacturer Narrative
Additional information; section h6 component code: in the initial report the component code was 4755 part/component/sub-assembly term not applicable and has been updated to read as component code 423 - cable, electrical.Section h3: device evaluation: service found foot pedal passed self-test but showed errors in event log.Engineering evaluated the foot pedal and found that the modes are advancing on its own and that the bt connection is intermittent.Engineering felt the cause was a bad cable.All pertinent information available to johnson & johnson surgical vision , inc has been submitted.

• Brand Name: VERITAS FOOTPEDAL
• Common Device Name: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 31 technology drive; irvine CA 92618
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15655444
• Report Number: 3012236936-2022-02630
• Device Sequence Number: 2428571
• Product Code: HQC
• UDI-Device Identifier: 05050474700871
• UDI-Public: (01)05050474700871
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K203060
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VRT680700
• Device Catalogue Number: VRT680700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VERITAS CONSOLE S/N (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown