D
Patient 1
DR ENDODONTISTS USE ENDOCHUCK ON THE MINIMUM POWER. JUST ONE LED INDICATOR FLASHES. AND EACH TIME A NEW TIP BREAKS INTO THE CHANNEL. DOCTORS WERE ABLE TO REMOVE BROKEN TIPS MOST OFTEN BUT ONE FRAGMENT COULD NOT BE REMOVED.
MAUDE MDR 4658383
- MDR report key
- 4658383
- Report number
- 3004096429-2015-00002
- Event key
- 0
- Event type
- 3
- Date received
- 2015-03-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MRS SILORET VIRGINIE
- Address
- CHEMIN DE LA VUARPILLIERE 31 NYON 1260 SZ
- Phone
- 122-122-1229
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SCALAR SYSTEM TIP, PERIODONTIC, ULTRASONIC | ENDOCHUCK | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. | EMN | UNK | UNK | UNK | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-03-27 | 0 | 1. O |
Event Narratives#
N
Patient 1
THE RISK OF INSTRUMENT BREAKAGE HAS ALREADY BEEN IDENTIFIED AND IS CLEARLY MENTIONED WITH OUR IFU FB-439/3 FOR PIEZON INSTRUMENTS AND WITHIN OUR RISK ANALYSIS (B)(4). THIS KIND OF BREAKAGE COULD BE CAUSED BY SEVERAL FACTORS. NEVERTHELESS, WE DO NOT RECEIVE ENOUGH INFO ON THIS CASE TO PROVIDE A FINAL CONCLUSION. THE USER COULD REFER TO INDICATIONS AND RECOMMENDATIONS (POWER SETTINGS) AND SPECIALLY ON THE TROUBLESHOOTING PART WITHIN OUR IFU FB-439/3 FOR PIEZON INSTRUMENTS. DESPITE TWO REMINDERS THE FOURTH AND TWENTIETH OF FEBRUARY, OUR DISTRIBUTOR HAS NOT SUCCEEDED IN COLLECTING MORE INFO ON THE SEVERITY OF THE INCIDENT AND ON THE CURRENT STATE OF HEALTH OF THE PT FOR THE TIME BEING. UPDATE 03/25/2015: FINAL REPORT. WE COULD NOT INVESTIGATE DEEPER ON THIS CASE. NO PRODUCT RETURN, NOT ENOUGH INFO PROVIDED ON THAT CASE. DESPITE OUR REMINDERS, WE HAVE ALSO NOT RECEIVED ANY INFO CONCERNING THE STATE OF HEALTH OF THE PT. OUR DISTRIBUTOR INFORMED US THAT HE RECEIVED A LETTER FROM THEIR DEALER IN LITHUANIA WHICH ASKED TO CLOSE THE CASE. THE DENTIST DOESN'T WANT TO COOPERATE ON THIS MATTER.