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

Model Number 690880

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The clinic is reporting this adverse event only and did not request or require field service or clinical support.All pertinent information available to abbott medical optics has been submitted.

Event Description

The surgery center reported the phacoemulsification handpiece had the inner insulated wires from the outer cable exposed.A brief description from the surgery center indicated that at the end of cable assembly connected the handpiece was coming apart; therefore the outer part of the cable was no longer protecting the inner insulated wires.The issue was noted when opening the instrument tray.The handpiece was taken out of circulation, therefore not used for surgeries.There no patient injury reported.

• 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: 5114709
• MDR Text Key: 27177283
• Report Number: 3006695864-2015-00666
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 09/30/2015

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: 690880
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2011
• 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