MAUDE Adverse Event Report: ALCON ¿ IRVINE TECHNOLOGY CENTER ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM; ENDOILLUMINATOR

Catalog Number 8065750290

Device Problems Device Displays Incorrect Message (2591); Operating System Becomes Nonfunctional (2996)

Patient Problem No Information (3190)

Event Date 08/19/2014

Event Type  Injury  

Event Description

A customer reported the equipment displayed a system message and locked during the procedure.The procedure was not completed.Additional information has been requested.

Manufacturer Narrative

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.(b)(4).

• Brand Name: ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
• Type of Device: ENDOILLUMINATOR
• Manufacturer (Section D): ALCON ¿ IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer (Section G): ALCON ¿ IRVINE TECHNOLOGY CENTER; 15800 alton pkwy.; irvine CA 92618
• Manufacturer Contact: janet moran ; 6201 south freeway, r3-48; fort worth, TX 76134 ; 8176152742
• MDR Report Key: 4101687
• MDR Text Key: 4840897
• Report Number: 2028159-2014-01588
• Device Sequence Number: 1
• Product Code: MPA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K951627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065750290
• Other Device ID Number: 1.05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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
• Patient Outcome(s): Required Intervention