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

Model Number NGP680301

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vitrectomy (2643)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Trouble-shooting with technical support (ts) was performed.Ts verified that bluetooth communication and connectivity between footpedal and console was working properly.A field service engineer (fse) was dispatched to customer site.The fse tested operation of the phaco system.No system issues were observed.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 mitigation's 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 the whitestar signature pro 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 complaint.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

Event Description

Lost communication between the footpedal and phaco system resulting in an unplanned vitrectomy was reported.A brief description from the surgery center indicated that during cataract removal surgery on (b)(6) 2020, the footpedal and phaco machine lost communication during a dense cataract procedure of a male patient¿s right eye (od).Vitrectomy was required.The cataract surgery was completed using the same phaco console.This report is for the whitestar signature pro console.A separate report will be submitted for the whitestar signature pro adv linear pedal.

• Brand Name: WHITESTAR SIGNATURE PRO CONSOLE
• Type of Device: WHITESTAR SIGNATURE PRO
• 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: 10729538
• MDR Text Key: 212971379
• Report Number: 3006695864-2020-00473
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: NGP680301
• Device Catalogue Number: NGP680301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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
• Patient Outcome(s): Required Intervention