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

Model Number	CMP680300
Medical Device Problem Codes	Device Emits Odor (1425); Smoking (1585)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/20/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The field service specialist (fss) visited customer site to inspect the unit.Fss confirmed the visible smoke issue with the unit and replaced the single board computer (sbc) printed circuit board (pcb) to rectify the problem.Fss performed the field service checklist, which the unit passed all functional tests and it was found to meet amo specifications.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
The account reported smell from the system, that visible smoke was observed with the sovereign compact console.There was no patient involvement reported and no patient treatments delayed or cancelled.
Additional Manufacturer Narrative
The 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 mitigations associated with the received 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.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: SOVEREIGN COMPACT CONSOLE
• Common Device Name: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6032881
• Report Number: 3006695864-2016-00875
• Device Sequence Number: 19002982
• Product Code: HQC
• UDI-Device Identifier: 05050474514706
• UDI-Public: (01)05050474514706
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K060366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2017

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
• Operator of Device: Physician
• Device Model Number: CMP680300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/20/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2016
• Supplement Report FDA Received Date: 01/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1