MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL

Model Number	NGP680703
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vitrectomy (2643)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Trouble-shooting with technical support (ts) was performed and operation of the foot pedal was tested remotely with the system test process.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 reconnected the footpedal and confirmed that it passed full function and calibration tests.Battery was charged at 100 percent.A review of records related to the whitestar signature pro adv linear pedal including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if any further relevant information is obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem 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 adv linear pedal.A separate report will be submitted for the whitestar signature pro adv linear console.
Additional Manufacturer Narrative
H4: the correct manufacturing date is 10/17/2017 as provided in this report.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

• Brand Name: WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL
• Common Device Name: WHITESTAR SIGNATURE PRO ADV LINEAR PEDAL
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10729543
• Report Number: 3006695864-2020-00474
• Device Sequence Number: 3060420
• Product Code: HQC
• UDI-Device Identifier: 05050474596122
• UDI-Public: (01)05050474596122
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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
• Operator of Device: Health Professional
• Device Model Number: NGP680703
• Device Catalogue Number: NGP680703
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention