MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR SIGNATURE FOOTPEDAL

Model Number	NGP680701
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The system was evaluated by a field service engineer.The field service found no issues with the unit, however, found the foot pedal not working properly.A loaner foot pedal was provided.A field service checklist was performed.All modes of operation and calibrations were verified.The unit complied with all factory settings.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
During a cataract procedure, the foot pedal failed and the procedure was not completed.The surgery center could not proceed with the completion of the cataract procedure.The procedure was completed the following day.No patient injury reported.
Additional Manufacturer Narrative
In initial report, the manufacturer year provided was inadvertently reported as 5/26/2011, however the correct date is january 2011.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Additional Manufacturer Narrative
This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: WHITESTAR SIGNATURE FOOTPEDAL
• Common Device Name: FOOTPEDAL
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 8668907
• Report Number: 3006695864-2019-00450
• Device Sequence Number: 2232947
• Product Code: HQC
• UDI-Device Identifier: 05050474534483
• UDI-Public: (01)05050474534483
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2020
• Report Date (Section F): 01/01/2005

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 Model Number: NGP680701
• Device Catalogue Number: NGP680701
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 10/25/2020
• Initial Report FDA Received Date: 06/04/2019
• Supplement Report FDA Received Date: 08/27/2019; 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONSOLE SN# (B)(6).
• Date Report Sent to FDA: 01/01/2005