Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ALCON-IRVINE TECH CTR ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM; ENDOILLUMINATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ALCON-IRVINE TECH CTR ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM; ENDOILLUMINATOR Back to Search Results
Catalog Number 8065750290
Device Problems Loss of Power (1475); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/10/2013
Event Type  malfunction  
Event Description
A customer reported that a system shut down on its own during a procedure.The system was exchanged and the surgery was completed with no harm to the patient.
 
Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 80356 when add'l reportable info becomes available.(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ACCURUS HIGH BRIGHTNESS ILLUMINATOR SYSTEM
Type of Device
ENDOILLUMINATOR
Manufacturer (Section D)
ALCON-IRVINE TECH CTR
15800 alton pkwy.
irvine CA 92618 381
Manufacturer (Section G)
ALCON MANUFACTURING, LTD.
15800 alton pkwy.
irvine CA 92618 381
Manufacturer Contact
janet moran
15800 alton pkwy.
irvine, CA 92618-3818
8176152742
MDR Report Key3697587
MDR Text Key4266276
Report Number2028159-2014-00035
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 Unknown
Type of Report Initial
Report Date 12/11/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2014
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 Received12/11/2013
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-