FDA Adverse Event Malfunction Summary report: N

ACCURUS 800CS

MDR report key: 2903308 · Received December 14, 2012

Report

Report Number: 2028159-2012-01954
Event Type: Malfunction
Date Received: December 14, 2012
Date of Event: November 12, 2012
Report Date: November 15, 2012
Manufacturer: ALCON - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K911808
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE CUSTOMER REPORTED A SYSTEM MESSAGE (SM) WAS DISPLAYED WHILE PRIMING THE CASSETTE. THE SYSTEM WAS EVENTUALLY RESTARTED AND THE SURGERY WAS PERFORMED WITH ANOTHER CASSETTE. THERE WAS NO SAMPLE RETURNED FOR EVALUATION AND NO ADDITIONAL INFORMATION PROVIDED RELATED TO THIS EVENT. FOR THIS REASON, STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE REPORTED EVENT. A REVIEW OF COMPLAINTS FOR THE LAST 24 MONTHS DID NOT INDICATE ANY ADDITIONAL SIMILAR REPORTS FOR THIS CASSETTE LOT NUMBER OR SYSTEM. THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. (B)(4).

Description of Event or Problem · 1

A SURGEON REPORTED THAT WHEN TESTING AND CALIBRATING THE PACK ON THE SYSTEM, WHILE CHOOSING "PASS TO THE TEST", THE SYSTEM DISPLAYED A MESSAGE AND TURNED OFF. THE SYSTEM WAS ABLE TO BE RESTARTED AFTER 15 MINUTES (ALL EARLIER ATTEMPTS TO RESTART THE SYSTEM HAD BEEN UNSUCCESSFUL). ANOTHER CASSETTE WAS USED AND THE PROCEDURE WAS ABLE TO BE PERFORMED. THE PATIENT HAD BEEN UNDER GENERAL ANESTHESIA AT THE TIME OF THE EVENT, AND ANESTHESIA HAD TO BE PROLONGED 20 MINUTES AS A RESULT. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCURUS 800CS	PHACOFRAGMENTATION SYSTEM	HQC	ALCON - IRVINE TECHNOLOGY CENTER	ACCURUS	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1				TOTAL PLUS VITREORETINAL PAK\| CUSTOM PAK