MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR SIGNATURE SYSTEM; PHACOEFRAGMENTATION UNIT

Model Number NGP680300

Device Problem Smoking (1585)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Date of event: date unknown.First name: unknown.(b)(6).The system was evaluated by a field service engineer.The field service found inverter was not working properly.The inverter was replaced.A field service checklist was performed.The unit complied with all factory settings.A review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that smoke came from the monitor.There was no patient involvement reported.No additional information was provided.

Manufacturer Narrative

In initial report, the manufacturer year provided was inadvertently reported as 4/26/2008, however the correct date is 4/23/2008.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

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 SYSTEM
• Type of Device: PHACOEFRAGMENTATION UNIT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9284223
• MDR Text Key: 165224623
• Report Number: 3006695864-2019-00879
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (y/n): Y
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NGP680300
• Device Catalogue Number: NGP680300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/06/2019
• Supplement Dates Manufacturer Received: 12/12/2019; 10/25/2020
• Supplement Dates FDA Received: 01/08/2020; 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1