MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS SOVEREIGN COMPACT CONSOLE; PHACOFRAGMENTATION UNIT

Model Number CMP680300

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device manufacture date: 2016.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that error 418 (footpedal error) occurred during operation with the sovereign compact console.The operation was delayed about thirty (30) min.It was indicated that the operation was postponed to the next day as the error was not resolved.There was no patient injury reported.

Manufacturer Narrative

Additional information provided indicated that the johnson and johnson vision field service engineer (fse), called customer and did the following troubleshooting over the phone: since 418 was an error of the foot pedal zero switch, various things such as pinching of foreign matter to the pedal part, sound of a physical switch, plugging in and unplugging and re-launching cables, and foot pedal test (0 to 100% stepping on confirmation) was checked, but the error 418 could not be cleared, the surgery was canceled on that day.The next day ((b)(6) 2018), fse visited customer site to prepare an alternative machine(intuitive) for performing the surgery and to provide the customer a replacement foot pedal.Device manufacture date: 4/2016.Manufacturing record review: a document labeling, trending and risk documentation reviews for this equipment were performed.The trend review shows that there is not a recognizable adverse trend.The risks and mitigation associated with the received complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.The operator manuals for the signature equipment was reviewed and determined to include adequate warnings for medical complications.The review of the device history record (dhr) for this system was also performed which showed that there were no issues or non-conformities.No deviations were reported.The device was documented as meeting all required specifications.Therefore, the manufacture of the device did not contribute to the reported complaint.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: SOVEREIGN COMPACT CONSOLE
• Type of Device: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 7217342
• MDR Text Key: 98285018
• Report Number: 3006695864-2018-00154
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474573628
• UDI-Public: (01)05050474573628
• Combination Product (y/n): N
• 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
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: CMP680300
• Device Catalogue Number: SCP680300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/09/2018
• Initial Date FDA Received: 01/24/2018
• Supplement Dates Manufacturer Received: 04/04/2018
• Supplement Dates FDA Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1