MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS WHITESTAR PHACO HANDPIECE (COAXIAL)

Model Number 690705

Device Problem Peeled/Delaminated (1454)

Patient Problem No Patient Involvement (2645)

Event Date 02/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(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 broken cable with exposed wires with an whitestar phaco handpiece.It was stated that the exposed wires were due to sterilization.There was no patient involvement/user injury reported.

• Brand Name: WHITESTAR PHACO HANDPIECE (COAXIAL)
• 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: 5474846
• MDR Text Key: 39527743
• Report Number: 3006695864-2016-00193
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 690705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2013
• 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