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

Model Number NGP680703

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 212972829
• Report Number: 3006695864-2020-00474
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474596122
• UDI-Public: (01)05050474596122
• 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
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: NGP680703
• Device Catalogue Number: NGP680703
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention