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

Model Number NGP680300

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Inappropriate or Unexpected Reset (2959)

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) i date of the event is the best estimate date of first onset of product problem reported.(b)(6).The phacoemulsification machine was examined and tested at the customer location by an amo field service specialist (fss).The fss confirmed the unit would freeze up.The fss replaced the instrument manager printed circuit board to resolve the freezing issue.The fss performed a field service checklist.The system was verified for all modes of operations.The system met amo specifications.All pertinent information available to abbott medical optics has been submitted.

Event Description

The surgery center reported the phacoemulsification unit was frozen.A brief description from the surgery center indicated the unit occasionally restarted itself after the system had frozen.The freezing reported did not cause a delay or cancellation of the cataract procedures.There is no patient involvement reported.

Manufacturer Narrative

A record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document and trending was reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the 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.

Manufacturer Narrative

Correction: in initial report the date of event that was entered ((b)(6) 2015).Clarification on the date was provided and it was learned the actual date of event was (b)(6) 2016.This follow up has the correct date of event.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: WHITESTAR SIGNATURE SYSTEM
• Type of Device: PHACOFRAGMENTION 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: 5375578
• MDR Text Key: 36634597
• Report Number: 3006695864-2016-00074
• Device Sequence Number: 1
• Product Code: HQC
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2016

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?: Yes
• Initial Date Manufacturer Received: 12/23/2015
• Initial Date FDA Received: 01/18/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/15/2016; 06/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2013
• 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