Device product
BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.
Z-0802-2020
Product summary
- Event
- Event 84367
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,024,890 devices
- Official record key
device-enforcement:Z-0802-2020
Official wording
Reason: The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.
Code information: Part Number/Lot Number 040-722U 181000115 I CCW 040-722U 181001520 I CCW 040-722U 181200006 I CCW 040-722U 181202055 I CCW 040-722U 190100006 I CCW
Distribution pattern: US: Nationwide OUS: Australia, Canada, China, Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK
Derived failure modes
-
Unknown
The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device. If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.