ILLUMISITE ILS-1800-KT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-21 for ILLUMISITE ILS-1800-KT manufactured by Covidien Lp - Superdimension Inc.

Event Text Entries

[182740438] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[182740439] According to the reporter during a procedure while using a cross country and once tunneled through the airway, when rotation of catheter occurred with nothing in the channel, the catheter twisted and kinked. No tools could be passed through. The physician was not able to complete the enb portion of the case. The patient is under conscious sedation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004962788-2020-00011
MDR Report Key9739891
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-21
Date of Report2020-03-26
Date of Event2020-02-04
Date Mfgr Received2020-03-18
Date Added to Maude2020-02-21
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAMY BEEMAN
Manufacturer Street161 CHESHIRE LANE, SUITE 100
Manufacturer CityMINNEAPOLIS MN 55441
Manufacturer CountryUS
Manufacturer Postal55441
Manufacturer Phone7632104064
Manufacturer G1COVIDIEN LP - SUPERDIMENSION INC
Manufacturer Street161 CHESHIRE LANE, SUITE 100
Manufacturer CityPLYMOUTH MN 55441
Manufacturer CountryUS
Manufacturer Postal Code55441
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameILLUMISITE
Generic NameSYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
Product CodeJAK
Date Received2020-02-21
Model NumberILS-1800-KT
Catalog NumberILS-1800-KT
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCOVIDIEN LP - SUPERDIMENSION INC
Manufacturer Address161 CHESHIRE LANE, SUITE 100 PLYMOUTH MN 55441 US 55441


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.