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

Model Number NGP680300

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, service history, and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.A labeling review was conducted; the operator manual for the system was reviewed and found to include adequate instructions for use, warnings and operational errors.The review of the device history record (dhr) for whitestar signature phaco system showed that there were no issues or non-conformities.The system and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Based on the investigation results there is no indication of a product quality deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints.

Event Description

Account reported smoke emitting from the phaco system.A brief description from the surgery center indicated that the system monitor was flickering and then there was smoke coming out of the equipment.The system was powered down and surgeries were postponed.No patient involvement or injury was reported.

• Brand Name: WHITESTAR SIGNATURE SYSTEM
• Type of Device: SIGNATURE
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10560544
• MDR Text Key: 207737558
• Report Number: 3006695864-2020-00440
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (y/n): Y
• Reporter Country Code: JP
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2020

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
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1