MalfunctionDZS
TYTIN
Received Apr 9, 2014
Report 1815757-2014-00003 · MDR key 3736180
Device
Product problems
- Device Operates Differently Than Expected
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
A DOCTOR ALLEGED THAT THE TYTIN AMALGAM WAS TOO GRAINY AND HARD TO CONDENSE DURING PROCEDURES FOR THREE (3) PATIENTS. THIS IS THE SECOND OF THREE (3) REPORTS.
Additional Manufacturer Narrative
SPECIFIC INFORMATION WITH REGARD TO PATIENT GENDER, AGE, AND WEIGHT WERE NOT PROVIDED. THE DOCTOR REMOVED THE AMALGAM AND REPEATED THE PROCEDURE, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED; THEREFORE, A PHYSICAL EVALUATION WAS PERFORMED ON A RETAINED SAMPLE OF THE PRODUCT, YIELDING RESULTS WITHIN SPECIFICATION FOR CARVE TIME.