MalfunctionEKR
SYBRONENDO
Received Oct 23, 2018
Report 2016150-2018-00056 · MDR key 7996367
Device
Product problems
- Application Program Problem: Dose Calculation Error
- Application Program Problem: Dose Calculation Error
Patient
Not reported
- No Code Available
- No Code Available
Narrative
Additional Manufacturer Narrative
NO PATIENT INFORMATION WAS PROVIDED IN REGARDS TO AGE, GENDER, ETHNICITY, AND RACE. DATE OF EVENT WAS NOT PROVIDED. NO INFORMATION WAS PROVIDED IN REGARDS TO THE SERIAL NUMBER, THEREFORE DEVICE MANUFACTURING DATE COULD NOT BE DETERMINED. FOLLOW UP ATTEMPTS WERE MADE FOR ADDITIONAL INFORMATION, HOWEVER THERE WAS NO RESPONSE. THE PRODUCT HAS BEEN IDENTIFIED AS A POTENTIAL AFFECTED PRODUCT IN AN ONGOING CLASS II RECALL; THEREFORE NO FURTHER EVALUATION IS NECESSARY.
Description of Event or Problem
AN ALLEGED COMPLAINT WAS REPORTED THAT THE BUCHANAN PLUGGER OVERHEATED THE GUTTA PERCHA AND IT GOT INTO THE NASAL CAVITY OF THE PATIENT.
Remedial action
- Recall