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

Model Number NGP680301

Device Problems Restricted Flow rate (1248); Loose or Intermittent Connection (1371); Suction Problem (2170)

Patient Problem Eye Burn (2523)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although, johnson & johnson(j&j) requested a site visit, the surgery center declined service at this time.After a few attempts, a j&j surgical account executive corresponded with the biomedical engineer.The j&j representative discussed the reported event and all the variables that could contribute to a corneal burn including the description that was reported event such as using vacuum settings, use of the tubing pack, and tip.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

During a cataract extraction procedure, a corneal burn occurred in the patient¿s operative eye when using the whitestar signature pro console.It was explained the treating resident performed the cataract procedure as the surgeon was watching through a microscope.The phaco handpiece was inserted into the operative eye.The resident depressed the footpedal and immediately there was a beeping warning sound to indicate an occlusion and smoking at the tip in the eye creating whitening at the corneal wound.The phaco pedal was depressed for a few seconds at most when the surgeon observing the procedure had the resident halt the procedure.At that time, the treating resident felt that the tubing may have been loose.The tubing pack was replaced, and the foot pedal was depressed to maximum and the beeping shortly thereafter disappeared.Although the surgeon commented that the treating resident was competent doing independent cases, the surgeon observing the case took over and completed the rest of the case carefully.The surgeon was not able to close the wound with corneal hydration.The surgeon attempted to place a figure 8 suture, which was not successful.The surgeon tried adding more long simple interrupted sutures which still did not provide closure.Eventually, the surgeon replaced the figure 8 suture and was able to have a formed anterior chamber with a slow leak.A bandage contact lens was placed on the eye and the patient was given aqueous suppressants.At a one-day post op exam, there was iris to the wound with a peaked pupil but fortunately the leak had stopped.The surgeon noted the remaining cataract procedures seemed to be more surging of the posterior capsule than normal and commented on the last case of the day, the posterior capsule bag was drawn into the phaco tip, however, commented the cases scheduled that day were completed successfully.

Manufacturer Narrative

Correction: in initial report, the manufacturing date was reported as 5/30/2017.The correct date is 4/6/2017.A review of the records related to the device that included labeling, manuals, trending, and risk documentation was performed.The review of the device history record (dhr) for the device 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.The trend review shows that there is not significant change over historical complaint limits and no recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.There was no product deficiency identified.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.

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: WHITESTAR SIGNATURE PRO
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9315413
• MDR Text Key: 166160326
• Report Number: 3006695864-2019-00895
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NGP680301
• Device Catalogue Number: NGP680301
• Was Device Available for Evaluation?: No
• 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
• Treatment: TUBING PACK, TIP AND HANDPIECE; TUBING PACK, TIP AND HANDPIECE
• Patient Outcome(s): Required Intervention