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

Model Number NGP680300

Device Problems Bent (1059); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The field service specialist (fss) visited customer site and upon inspection of the unit, the reported issue was confirmed.Fss replaced the bottle hanger assembly and performed the field service checklist on the unit.The system passed and it was found to meet amo specifications.All pertinent information available to abbott medical optics has been submitted.

Event Description

The surgery center reported that the bottle hanger was bent and pin came off with the whitestar signature system.There was no patient involvement reported and no patient treatments delayed or cancelled.

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.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: 5237854
• MDR Text Key: 31673417
• Report Number: 3006695864-2015-00841
• 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: 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: 10/27/2015
• Initial Date FDA Received: 11/19/2015
• 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: 10/26/2012
• 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