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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MILLER 2; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH POLARIS FO BLADE MILLER 2; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 4150020
Device Problem Optical Obstruction (3002)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported the light source was blocked by the patient tongue and anatomy which prevented the light from being visible to see the patient vocal cords.It was reported the anesthesia team had to use a glidescope in order to intubate the patient.No patient harm was reported.
 
Manufacturer Narrative
Qn#(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.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
Customer reported the light source was blocked by the patient tongue and anatomy which prevented the light from being visible to see the patient vocal cords.It was reported the anesthesia team had to use a glidescope in order to intubate the patient.No patient harm was reported.
 
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Brand Name
RUSCH POLARIS FO BLADE MILLER 2
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key9168376
MDR Text Key163575556
Report Number3011137372-2019-00345
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 09/18/2019
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 No Information
Device Catalogue Number4150020
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/18/2019
Initial Date FDA Received10/08/2019
Supplement Dates Manufacturer Received11/05/2019
Supplement Dates FDA Received11/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
GLIDESCOPE; GLIDESCOPE
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