MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-03-27 for SCALAR SYSTEM TIP, PERIODONTIC, ULTRASONIC UNK manufactured by E.m.s. Electro Medical Systems S.a..
[5679670]
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.
Patient Sequence No: 1, Text Type: D, B5
[13179148]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004096429-2015-00002 |
| MDR Report Key | 4658383 |
| Report Source | 08 |
| Date Received | 2015-03-27 |
| Date of Report | 2015-02-25 |
| Date Added to Maude | 2015-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MRS SILORET VIRGINIE |
| Manufacturer Street | CHEMIN DE LA VUARPILLIERE 31 |
| Manufacturer City | NYON 1260 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 1260 |
| Manufacturer Phone | 1229944700 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCALAR SYSTEM TIP, PERIODONTIC, ULTRASONIC |
| Generic Name | ENDOCHUCK |
| Product Code | EMN |
| Date Received | 2015-03-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | E.M.S. ELECTRO MEDICAL SYSTEMS S.A. |
| Manufacturer Address | CHEMIN DE LA VUARPILLIERE 31 NYON 1260 SZ 1260 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-27 |