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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON - IRVINE TECHNOLOGY CTR ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM; ENDOILLUMINATOR
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ALCON - IRVINE TECHNOLOGY CTR ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM; ENDOILLUMINATOR Back to Search Results
Catalog Number 8065750290
Device Problems Operating System Becomes Nonfunctional (2996); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/19/2014
Event Type  malfunction  
Event Description
A customer reported the system shut down during a case.The system was exchanged to complete the case.There was no impact to the pt.
 
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 info becomes available.(b)(4).
 
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Brand Name
ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
Type of Device
ENDOILLUMINATOR
Manufacturer (Section D)
ALCON - IRVINE TECHNOLOGY CTR
15800 alton pkwy.
irvine CA 92618
Manufacturer (Section G)
ALCON - IRVINE TECH CTR
15800 alton pkwy.
irvine CA 92618
Manufacturer Contact
janet moran
6201 south freeway, r3-48
fort worth, TX 76134
8176152742
MDR Report Key3834529
MDR Text Key4404637
Report Number2028159-2014-00416
Device Sequence Number1
Product Code MPA
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K951627
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other
Type of Report Initial
Report Date 02/20/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number8065750290
Other Device ID Number1.18-2.18
Was Device Available for Evaluation? No
Date Manufacturer Received02/20/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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