MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS ELLIPS FX PHACO HANDPIECE

Model Number 690880

Device Problems Material Frayed (1262); Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Phone number: (b)(6).Customer did not request for a field service specialist visit to the site.An accessory exchange was requested.The handpiece was not under warranty and it was not returned to amo.All pertinent information available to abbott medical optics has been submitted.

Event Description

The customer reported exposed wires with the ellipse fx phaco handpiece due to damaged main insulation on the connector side.No patient involvement/injury reported.

Manufacturer Narrative

Through follow ups with the abbott senior sales representative, it was learned that the handpiece wire was not frayed.That there would not have been any issues with the equipment not performing per its intended use due to the reported wire issue if the handpiece would be used and that it could not result in a serious injury to the patient or the user.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Type of Device: PHACO HANDPIECE
• 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: 5523624
• MDR Text Key: 41075389
• Report Number: 3006695864-2016-00286
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 690880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2010
• 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