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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MILLER 4; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MILLER 4; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 4150040
Device Problem Optical Obstruction (3002)
Patient Problem No Patient Involvement (2645)
Event Date 10/10/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Complaint alleges the light pipe was blocked by tongue tissue during a tracheal intubation on a cadaver.It was reported the tongue tissue folded over in front of the light pipe causing darkness in the throat.
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.While the complaint cannot be confirmed without a physical sample, historical complaint data was reviewed and several occurrences of similar complaints (light blockage with polaris blades) were identified.The previous complaints have resulted in the initiation of a capa to address a customer preference issue related to the functional use of the polaris blades.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Complaint alleges the light pipe was blocked by tongue tissue during a tracheal intubation on a cadaver.It was reported the tongue tissue folded over in front of the light pipe causing darkness in the throat.
 
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Brand Name
RUSCH POLARIS FO BLADE MILLER 4
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key9284257
MDR Text Key166760034
Report Number3011137372-2019-00382
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4150040
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/16/2019
Initial Date FDA Received11/06/2019
Supplement Dates Manufacturer Received11/25/2019
Supplement Dates FDA Received11/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED; NONE REPORTED
Patient Age75 YR
Patient Weight52
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