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

Model Number	NGP680300
Medical Device Problem Codes	Unintended Ejection (1234); Device Emits Odor (1425); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Pain (1994); No Code Available (3191)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(b)(4).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 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 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 all pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
The surgery center reported a cataract patient had an unplanned suture placed on incision and was presented with corneal opacification and pain resulting in medical treatment outside the normal regime.A description of the event is that after the anterior capsule incision was created, the sound of the tubing pack ejecting was heard from the whitestar signature phaco system; the system proceeded to the end of the procedure and shut down.At the same moment, there was a burnt odor.Although, there was no visible smoke, the decision was made to complete the procedure using a backup machine.A 3-hour delay was reported while waiting for a backup system to arrive at the site location.The incision was temporarily closed while waiting for the machine arrival.Follow up was provided: on the day of procedure, the surgeon thought it was a potential risk for patient injury.However, on the day 1 postoperatively, it turned out the patient was well, the surgeon was relieved.It was explained the opacification was due to the dried epithelium, which caused pain in eye on the day of procedure.However, on the day 1 postoperatively, the patient did not claim pain, and the outcome seemed well.

• Brand Name: WHITESTAR SIGNATURE SYSTEM
• Common Device Name: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10532323
• Report Number: 3006695864-2020-00431
• Device Sequence Number: 3336418
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (Y/N): Y
• Initial Reporter Country: JP
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

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: NGP680300
• Device Catalogue Number: NGP680300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 09/14/2020
• 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