FDA Adverse Event Malfunction Summary report: N

INFINITI VISION SYSTEM OZIL

MDR report key: 1823644 · Received August 27, 2010

Report

Report Number: 2028159-2010-01585
Event Type: Malfunction
Date Received: August 27, 2010
Date of Event: July 28, 2010
Report Date: July 28, 2010
Manufacturer: ALCON - IRVINE TECHNOLOGY CTR
Product Code: HQC
PMA / PMN Number: K082845
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

THE COMPANY SERVICE REPRESENTATIVE EXAMINED THE SYSTEM AND CONFIRMED THE SYSTEM MESSAGE REPORTED. THE FOOTSWITCH CABLE WAS REPLACED. THE CUSTOMER NEEDED THE SYSTEM FOR SURGERY IMMEDIATELY AND THE SYSTEM WAS NOT TESTED PER THE SERVICE TEST PROCEDURE. THE COMPANY SERVICE REPRESENTATIVE REMAINED ONSITE AND OBSERVED THE FIRST CASE TO VERIFY THE PROPER FUNCTION OF THE SYSTEM. NO FURTHER PROBLEMS WERE NOTED. THE FOOTSWITCH CABLE HAS BEEN RECEIVED AND IN-HOUSE TESTING IS IN PROGRESS. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY WHEN ADDITIONAL REPORTABLE INFO BECOMES AVAILABLE. (B)(4).

Description of Event or Problem · 1

ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "SYSTEM MESSAGE DISPLAYED" (DEVICE DISPLAYS ERROR MESSAGE). THE CUSTOMER REPORTED A SYSTEM MESSAGE DISPLAYED DURING SURGERY. THE CASE WAS DELAYED. ADDITIONAL INFO RECEIVED FROM THE COMPANY SERVICE REPRESENTATIVE STATED HE WAS ONSITE AN HOUR AFTER THE CUSTOMER CALLED FOR SERVICE. THE CUSTOMER WAS RUNNING ONE OPERATING ROOM INSTEAD OF THE TWO USUAL OPERATING ROOMS. NO PT INJURY WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	INFINITI VISION SYSTEM OZIL	PHACOFRAGMENTATION SYSTEM	HQC	ALCON - IRVINE TECHNOLOGY CTR	INFINITI OZIL	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK