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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL DEVICES GREENLINE; LARYNGOSCOPE
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MEDICAL DEVICES GREENLINE; LARYNGOSCOPE Back to Search Results
Model Number 5-0236-91
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/18/2019
Event Type  malfunction  
Manufacturer Narrative
Affected devices were returned.Each handle was reviewed visually and there is no evidence of damage or abuse to any of the handles.Each handle was returned with batteries installed and after a miller 3 blade was installed onto each handle to confirm the led's would illuminate, each handle was disassembled per the ifu instructions to check the lamp cartridge for proper installation.Seven (7) of the handles did not have the lamp cartridge fully threaded into the head so they were hand tightened and the devices functioned as intended.The remaining handle did not have the lamp cartridge installed into the laryngoscope head and full out completely.This lamp cartridge was threaded into the head per the ifu and the device functioned as intended.Proper installation of the lamp cartridge per the ifu provided a fully functionally and illuminating device.Therefore, the customer complaint is not confirmed.
 
Event Description
The customer alleges the "light flickers''.No other details were provided and no patient injury/harm reported.
 
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Brand Name
GREENLINE
Type of Device
LARYNGOSCOPE
Manufacturer (Section D)
MEDICAL DEVICES
wazirabad road, ugoki.
sialkot punjab, pakistan
MDR Report Key8540685
MDR Text Key143601659
Report Number1314417-2019-00020
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number5-0236-91
Device Lot NumberSJ
Was Device Available for Evaluation? Yes
Type of Device Usage N
Patient Sequence Number1
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