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

Model Number 690880

Device Problems Stretched (1601); Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of event: at the time of this report, the date of the event is unknown.(b)(6).Customer did not request for a field service specialist visit to the site.Only an accessory exchange was requested.All pertinent information available to abbott medical optics has been submitted.

Event Description

The customer reported breakage of cable isolation with an ellips fx phaco handpiece and pulled off the device from using.Customer observed breakage on another handpiece at the point of connection with handpiece body.It was reported that the personnel were precisely instructed how to handle all amo's equipment and phaco accessories (sterilization process accordingly to product manual and amo's instruction for use) and to strictly adhere to apply required protocols and processing recommended by amo.This report pertains to the first handpiece.A separate report will be submitted for the second handpiece issue.

• 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: 5565509
• MDR Text Key: 42272698
• Report Number: 3006695864-2016-00382
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/09/2016

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: Physician
• Device Model Number: 690880
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 04/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2014
• 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