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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX GREEN RUSCHLITE SOURCE, CARRIER, FIBEROPTIC LIGHT

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TELEFLEX GREEN RUSCHLITE SOURCE, CARRIER, FIBEROPTIC LIGHT Back to Search Results
Model Number 4551003
Device Problems Loose or Intermittent Connection (1371); Optical Problem (3001)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2015
Event Type  malfunction  
Event Description
An hour after return form cardiac surgery there was a loss of airway and attempts at various interventions, one of which involved the use of a disposable fiber-optic laryngoscope handle and blade assembly. Generally, the blade felt fully engaged but it was not. Light was projecting posteriorly with a dimmer projected light at the tip. This gave the end-user a false sense that the scope is ready to use which may contribute to a negative patient event.
 
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Brand NameGREEN RUSCHLITE
Type of DeviceSOURCE, CARRIER, FIBEROPTIC LIGHT
Manufacturer (Section D)
TELEFLEX
3015 carrington mill boulevard
morrisville NC 27560
MDR Report Key5343127
MDR Text Key35014807
Report Number5343127
Device Sequence Number1
Product Code EQH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/11/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number4551003
Device Catalogue NumberHANDLE 77700
Other Device ID NumberBLADE MAC THOUGHT TO BE SIZE
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2015
Event Location Hospital
Date Report to Manufacturer11/11/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/05/2016 Patient Sequence Number: 1
Treatment
MECHANICAL VENTILATION, ECMO SET UP
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