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

Model Number NGP680300

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: unknown.Information in section f provided by the manufacturer.The field service specialist (fss) inspected the signature system on customer site.The fss performed check disk with fix on hard drive and reloaded system software.Fss restarted system 8 times and system did not lock up.Fss performed system checklist and the unit was found to meet amo specification.All pertinent information available to abbott medical optics has been submitted.

Event Description

The account reported that the system boots up and freezes.It never gets to the main menu and they have to reboot system and it will boot up fine.There was no patient involvement reported and no patient treatments delayed or cancelled.

Manufacturer Narrative

Additional information: 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 monthly report for the time period of when amo was notified of the event does not show any significant change over historical complaint limits.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.The operator manuals for the signature equipment was reviewed and determined to include adequate warnings for medical complications.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: 5012723
• MDR Text Key: 24554550
• Report Number: 3006695864-2015-00525
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 11/17/2015

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: Not provided
• Initial Date FDA Received: 08/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2012
• 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