MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER ACCURUS SURGICAL SYSTEM; UNIT, PHACOFRAGMENTATION

Model Number 800CS

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A service visit was performed.

Manufacturer Narrative

Evaluation summary: the system was examined.The company representative did not indicate finding any issues related to the reported event.The system messages (sms) were confirmed (via event log).The power supply was replaced as a preventive measure.The system was tested and found to meet product specifications.The product met specifications at the time of release.The root cause cannot be determined conclusively.

Event Description

A hospital service technician informed that a nurse reported that the system screen got stuck during a procedure.While the surgeon was operating in the posterior segment, the silicone function was selected and the screen got stuck to vented gas-forced infusion (vgfi) parameter.It was not possible to come back to surgery function.The system had to be restarted to continue the procedure.Additional information has been requested but not received to date.This is one of two reports being filed for this facility.This report is for the second patient.

Manufacturer Narrative

A service visit was scheduled.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Additional information has been requested but not received to date.

• Brand Name: ACCURUS SURGICAL SYSTEM
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: janet moran ; 6201 south freeway; mail stop r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4566982
• MDR Text Key: 13275666
• Report Number: 2028159-2015-05115
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K911808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 800CS
• Device Catalogue Number: 8065741008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 03/04/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/09/2015; 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2006
• 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
• Patient Outcome(s): Other