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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HANDLE LARYNG F/O LED DISP; LARYNGOSCOPE, RIGID

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HANDLE LARYNG F/O LED DISP; LARYNGOSCOPE, RIGID Back to Search Results
Model Number 10889942162710
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Date 01/06/2019
Event Type  malfunction  
Event Description
During the intubation of a pt, the laryngeal scope broke off.(b)(4).Us.
 
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Brand Name
HANDLE LARYNG F/O LED DISP
Type of Device
LARYNGOSCOPE, RIGID
MDR Report Key8239893
MDR Text Key133333708
Report NumberMW5083073
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10889942162710
Device Lot Number18KBB847
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
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