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

Model Number NGP680300

Device Problems Device Emits Odor (1425); Smoking (1585); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/22/2016

Event Type  malfunction  

Manufacturer Narrative

Device manufacture date: 2015.(b)(6).The field service specialist (fss) visited customer site to inspect the unit.Fss checked and found the rear panel controller (rpc) printed circuit board assembly (pcb) had burned out and the power distribution cable was faulty.Fss replaced the rear panel controller and power distribution cable assembly.Fss then checked for all parameter as per field service check list, which all values were found to be within the limits as per amo specifications.Through follow ups, fse confirmed that there was no other visible evidence of fire/shock/explosion and no visible smoke was observed by him.That, there was no charring/melting of the power distribution cable; the cable was faulty due to connection at the inner point, and the burn had only happened on the rear panel controller pcb.All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that the whitestar signature system was non-functional with visible smoke, giving the burning smell and goes to safe mode.There was no patient involvement reported and no patient treatments delayed or cancelled.

Manufacturer Narrative

The device manufacture date of 2015 was listed in the initial mdr.Included in the device evaluation information it was indicated that the device manufacturing date was 07/2015.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.The review of the device history record (dhr) for this system was also performed which showed that there were no issues or non-conformities and that the system and its components met all specifications prior to being released.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: 6039036
• MDR Text Key: 57806391
• Report Number: 3006695864-2016-00880
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474534476
• UDI-Public: (01)05050474534476
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: NGP680300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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