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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE SIZE UNKNOWN; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENLITE SIZE UNKNOWN; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number MEDICAL UNKNOWN
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "a piece of plastic breaks off when folding blade /handle after intubation and these pieces could remain/fall in the patient's mouth.".No patient harm was reported.Patient's condition reported as "ok".
 
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.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It was reported "a piece of plastic breaks off when folding blade /handle after intubation and these pieces could remain/fall in the patient's mouth.".No patient harm was reported.Patient's condition reported as "ok".
 
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Brand Name
RUSCH GREENLITE SIZE UNKNOWN
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key9930256
MDR Text Key189446565
Report Number8030121-2020-00055
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 distributor,foreign
Type of Report Initial,Followup
Report Date 03/20/2020
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 NumberMEDICAL UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/20/2020
Initial Date FDA Received04/06/2020
Supplement Dates Manufacturer Received05/07/2020
Supplement Dates FDA Received05/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ULTRA-POWER LED HANDLE; ULTRA-POWER LED HANDLE
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