MalfunctionNOF
CS 3600 SINGLE USE NORMAL TIPS
Received Feb 23, 2021 · Event occurred Jan 25, 2021
Report 1317307-2021-00001 · MDR key 11366583
Device
Generic name
Cs 3600 Single Use Normal Tips
Manufacturer
Carestream Dental LlcModel number
CS 3600Catalog number
5941216
Lot number
2020-06
Product problems
- Material Separation
- Defective Component
- Material Separation
- Defective Component
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Description of Event or Problem
WHEN USING THE CS 3600 ACCESSORY: CS 3600 SINGLE USE NORMAL TIP, THE MIRROR CAN BE DETACHED FROM THE UNIT. WHEN THIS EVENT OCCURRED, THE MIRROR FELL FROM THE UNIT INTO THE PATIENT'S MOUTH. THE PATIENT WAS ABLE TO REMOVE THE MIRROR AND THE PATIENT DID NOT SUSTAIN ANY INJURIES. THE SIZE OF THE MIRROR (22MMX13MMX1.5MM) MAKES IT POSSIBLE FOR THE MIRROR TO BE SWALLOWED OR ASPIRATED. IF THE MIRROR IS SWALLOWED OR ASPIRATED, SURGICAL INTERVENTION WOULD BE REQUIRED TO REMOVE THE MIRROR.
Remedial action
- Recall