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

Model Number VRT680700

Device Problems Mechanical Problem (1384); Inappropriate or Unexpected Reset (2959)

Patient Problem Eye Injury (1845)

Event Date 09/23/2022

Event Type  Injury  

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 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.

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
• Type of Device: 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
• MDR Text Key: 302242259
• Report Number: 3012236936-2022-02630
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474700871
• UDI-Public: (01)05050474700871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203060
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/23/2022
• Initial Date FDA Received: 10/21/2022
• Supplement Dates Manufacturer Received: 02/09/2023
• Supplement Dates FDA Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: VERITAS CONSOLE S/N (B)(6).
• Patient Outcome(s): Required Intervention