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 Displays Incorrect Message (2591)

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

Event Date 04/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The field service specialist (fss) checked ethernet cable and it was connected well.The amo technical support specialist provided support to the fss and suggested to have the two parts, versalogic printed circuit board assembly (pcba) and 2b rohs programmed module were replaced on the unit.It was noted that after switching machine on, if fss did not press on touch screen for minutes, the machine would freeze and if fss selected any mood, it would wait for two (2) minutes to respond.Another attempt was made to repair the unit and fss replaced the advantech single board computer (sbc) and hard drive and tested the unit for two hours, which it was fine.Fss reported that in the operating room after surgeon finished on patient, software froze or had a slow response (1 minute), that there was no error message and when he restarted the system, it worked.Technical support specialist confirmed that the software and firmware were correct.Fss connected the ethernet cable to the other ethernet port (on the new advantech) and when checked the system again, it would freeze.After repairs system is still experiencing the error.System replacement was approved.All pertinent information available to abbott medical optics has been submitted.

Event Description

The customer reported that the system freezes with all programs and error 2012 (instrument host timeout error) occurs sometimes during surgery, which they must restart the system.The initial report indicated that there was no patient involvement reported and no patient treatments delayed or cancelled.

Manufacturer Narrative

Corrected data- the following information was not mentioned in the initial report that the touch screen was also replaced by the field service specialist in addition to the replacement of versa-logic printed circuit board assembly (pcba) and 2b rohs programmed module.Additional information- through follow up, it was reported that the system freezes suddenly, may be in ten (10) seconds after start up, sometimes during surgery, may be after some cases.When asked in this case, if the issue was during surgery, the response was "yes, three (3) times".It was stated that there was no patient injury and no medical interventions were required.Further follow ups were made with the account contact person, to clarify whether the issue occurred three (3) times during the same procedure or if the issue occurred at three (3) different times; however, no additional information /response was received.All pertinent information available to abbott medical optics has been submitted.

Manufacturer Narrative

Additional information: further follow ups were made with the account contact person, to clarify whether the issue occurred three (3) times during the same procedure or if the issue occurred at three (3) different times; however, the contact person was not able to provide precise information and stated that he did not exactly know, that he attended one case with doctor during phaco 1 and that sometimes the problem appeared after start-up directly.The customer still has the unit; however, system replacement has been approved.Results codes: an additional results code was used to capture the electrical problem.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.The operator manuals for the signature equipment was reviewed and determined to include adequate warnings for medical complications.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: 5139371
• MDR Text Key: 28173468
• Report Number: 3006695864-2015-00685
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: Other
• Type of Report: Followup,Followup
• Report Date: 12/02/2015

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: 10/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/03/2015; 12/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2014
• 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