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

Model Number NGP680300

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Inoperable (1663)

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

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The field service specialist (fss) visited customer site to inspect the unit.Fss could not duplicate the reported event during testing.Fss noted numerous error 282 (phaco handpiece errors) in the error log corresponding to reported lock ups.Initial customer handpiece provided (serial no.(b)(4)) failed with 282 error twice.Fss used another handpiece and the system passed prime/tune.Per fss, operator manual states that system power should be cycled after 282 error.This procedure was not always implemented and fss determined to be root the cause for system lock up since high voltage power is affected.When examining customer's failure log, fss discovered that third party rework service was being used for handpieces and same failure was noted on same serial number after rework on more than one occasion.Customer stated that they purchased new fx handpieces from amo and will implement using them on this system and monitor for any future issue.Fss completed the field service checklist, which the unit passed and it was found to meet amo specifications.All pertinent information available to abbott medical optics has been submitted.

Event Description

The customer reported of the whitestar signature system freezing/locking up in the middle of cases.The customer did a reboot but eventually it happened again.It was reported that the patient was on table when the event occurred; however, there was no patient injury reported.According to the initial report no patient treatments delayed or cancelled.

Manufacturer Narrative

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 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.Placeholder.

• 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: 5361912
• MDR Text Key: 36265098
• Report Number: 3006695864-2016-00044
• 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: Initial,Followup
• Report Date: 01/27/2016

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: 12/17/2015
• Initial Date FDA Received: 01/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2011
• 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