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

Model Number NGP680301

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

The system was evaluated by a field service engineer.The field service found the iv pole hanger was loose.The iv pole assembly was repaired.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

During a field service evaluation, the surgery center reported that the iv pole hanger was loose on a whitestar signature pro console.No patient involvement reported.

Manufacturer Narrative

H4: correction: in initial report, the manufacture date reported, (b)(6) 2016 was incorrect.The correct manufacture date is (b)(6) 2016.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.H3 other text : placeholder.

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 PRO CONSOLE
• Type of Device: PHACOEFRAGMENTAION UNIT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9656054
• MDR Text Key: 178189423
• Report Number: 3006695864-2020-00079
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474596146
• UDI-Public: (01)05050474596146
• Combination Product (y/n): Y
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NGP680301
• Device Catalogue Number: NGP680301
• 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
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1