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U.S. Department of Health and Human Services

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

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JOHNSON & JOHNSON SURGICAL VISION, INC. VERITAS FOOTPEDAL; UNIT, PHACOFRAGMENTATION Back to Search Results
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.
 
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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 Key15655444
MDR Text Key302242259
Report Number3012236936-2022-02630
Device Sequence Number1
Product Code HQC
UDI-Device Identifier05050474700871
UDI-Public(01)05050474700871
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203060
Number of Events Reported1
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 NumberVRT680700
Device Catalogue NumberVRT680700
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 Received10/21/2022
Supplement Dates Manufacturer Received02/09/2023
Supplement Dates FDA Received03/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
VERITAS CONSOLE S/N (B)(6).
Patient Outcome(s) Required Intervention;
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