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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN ILLUMISITE ENDOBRONCHIAL PROCEDURE KIT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
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COVIDIEN ILLUMISITE ENDOBRONCHIAL PROCEDURE KIT; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED Back to Search Results
Catalog Number ILS-0900-KT
Device Problems Activation, Positioning or Separation Problem (2906); Device Sensing Problem (2917); Compatibility Problem (2960)
Patient Problem Insufficient Information (4580)
Event Date 06/01/2021
Event Type  malfunction  
Event Description
In minor procedure area, a medtronic illumisite endobronchial device was deployed for use.It did not function properly.The locatable guide did not register the central airway appropriately.It was reading "out of sensing volume" and "out of central airway" when it was in the airway.There was discordance between reality and the computer system.Item was saved and taken to cart outside inventory support's office.The item was wasted in epic intraope supplies; and another was opened and used.
 
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Brand Name
ILLUMISITE ENDOBRONCHIAL PROCEDURE KIT
Type of Device
SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key12127640
MDR Text Key260266809
Report Number12127640
Device Sequence Number1
Product Code JAK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberILS-0900-KT
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/04/2021
Event Location Hospital
Date Report to Manufacturer07/07/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age22265 DA
Patient Weight88
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