MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS WHITESTAR SIGNATURE SYSTEM; PHACOFRAGMENTATION UNIT

Model Number NGP680300

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The field service specialist (fss) visited customer site to inspect the unit.Fss confirmed the white screen and replaced the instrument manager and hard drive.Fss updated the host software, calibrated the vacuum and performed the checklist for the biannual preventative maintenance (pm), which several filters and batteries were replaced on the unit as part of the pm.While on site, fss replaced the hanger and top cover since they were damaged.Since the fss found the screen flickering, he replaced the monitor assembly which resolved the issue.The system was found to meet amo specifications.The system was monitored until (b)(6) 2016, which monitoring period was successfully completed with no further issues.All pertinent information available to abbott medical optics has been submitted.

Event Description

While the field service engineer (fss) was on customer site, he found the hanger was broken and the top cover was damaged on the whitestar signature system.The customer also reported blank/black/frozen screen.That the screen goes black and loses brightness during use, even if the rest of the features remain in effect, running the prime and hear the prime warning is complete.It was stated that last week, for a white screen, the instrument manager and the hard drive was changed and this time the amo product technical support specialist suggested that the field service engineer (fss) to order and replace the complete monitor assembly.There was no patient involvement reported and no patient treatments delayed or cancelled.This report pertains to broken hanger issue.A separate mdr report will be submitted for the reported blank/black/frozen screen issue.

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: WHITESTAR SIGNATURE SYSTEM
• Type of Device: PHACOFRAGMENTATION UNIT
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: lourdes guevara ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478497
• MDR Report Key: 5517524
• MDR Text Key: 40940512
• Report Number: 3006695864-2016-00283
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/13/2016

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: Health Professional
• Device Model Number: NGP680300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1