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 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).The field service specialist (fss) revisited customer site and the issue was confirmed.Fss requested for a handpiece replacement to be done.The handpiece was replaced with another one with (b)(4) which resolved the issue.In a follow up with the field service specialist, he indicated that the wires were not frayed, only the coating was damaged.Fss determined that the issue could result in equipment not performing per its intended use and it could cause an electrical surge or short that could result in a serious injury to the patient or the user; therefore, he requested for a handpiece replacement.All pertinent information available to abbott medical optics has been submitted.

Event Description

The customer reported that the ellips fx phaco handpiece cable coating peeled.There was no patient involvement reported and no patient treatments delayed or cancelled.

Manufacturer Narrative

The device manufacturing record review was performed and no non-conformances for this handpiece was found.The product met manufacturing release criteria.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: 5662859
• MDR Text Key: 45414411
• Report Number: 3006695864-2016-00503
• 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: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• 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: 07/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2011
• 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