FDA Adverse Event Malfunction Summary report: N

ACCURUS 800CS

MDR report key: 1842597 · Received September 1, 2010

Report

Report Number: 2028159-2010-01649
Event Type: Malfunction
Date Received: September 1, 2010
Report Date: August 2, 2010
Manufacturer: ALCON - IRVINE TECHNOLOGY CENTER
Product Code: HQC
PMA / PMN Number: K911808
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

A COMPANY SERVICE REP EXAMINED THE SYSTEM AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEMS. PREVENTIVE MAINTENANCE WAS PERFORMED ON THE SYSTEM. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECIFICATIONS. A REVIEW OF COMPLAINTS AND SERVICE REQUESTS FOR THE LAST 24 MONTHS INDICATED NO ADDITIONAL, RELATED REPORTS FOR THIS SYSTEM. NO SAMPLE WAS RETURNED. THE COMPANY SERVICE REP WAS UNABLE TO REPLICATE OR CONFIRM THE REPORTED EVENT IN THE FIELD AND FOUND THE SYSTEM TO MEET SPECIFICATION. THEREFORE, EVALUATION STEPS COULD NOT BE TAKEN TO REPLICATE OR CONFIRM THE CUSTOMER REPORTED EVENT AND THE ROOT CAUSE IS THEREFORE, UNK AT THIS TIME. (B)(4).

Description of Event or Problem · 1

ADVERSE EVENT(S): " NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "PRESSURE PROBLEM" (PRESSURE ISSUE). A NURSE REPORTED THAT ONE SURGEON HAS NOTED LOW INFUSION PRESSURE. THE FACILITY NOTED THAT THIS SURGEON REPORTS THIS PROBLEM WITH CONSISTENCY EVERY COUPLE OF MONTHS AND THAT NO OTHER STAFF MEMBERS OR SURGEONS HAVE NOTED THIS PROBLEM. THERE WERE NO PTS IMPACTED AND ALL CASES WERE COMPLETED. THIS IS THE SECOND OF 2 REPORTS BEING FILED FOR THIS FACILITY.

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