MAUDE Adverse Event Report: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. INSTRUMENT ESI STARTER KIT; ENDO BASIC CLEANING 015

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

A standard root canal treatment was being performed on patient by a general dentist, not a specialist.During treatment an endo file broke into four pieces and part of the file is still stuck in root canal because the doctor could not get file out.Doctor was able to complete the root canal treatment on other canals on the same tooth.X-ray showed that the canal with the tip was not filled.The entire procedure was completed and a crown was already put on.The patient was advised that she could be referred to a specialist or the office could continue to monitor the situation with the future possibility of removing the tooth and replacing with an implant.At this point the patient opted to continue to monitor.Imp ref#: (b)(4).

Manufacturer Narrative

According to the products returned, we did not received the broken file.Nevertheless, the ds-010 endochuck and the 3x dt-068 files (contained in (b)(4)) returned does not present any defect.Moreover, according to our incoming inspection reports, we did not notice any deviation on these batches and we have not registered any similar complaints from the market.The risk of file breakage has already been identified and is clearly mentioned with our ifu fs-439/3 for piezon instruments and within our risk analysis tfr-016.Nevertheless, based on the info reported by our distributor (b)(4), the dentist used a parkell turbo piezo ultrasonic as equipment, as a result, we could not provide any info on this case.Ems gives some indications and recommendations (power settings.) within our ifu fb-439/3 which are related to ems device but which could not be applied to competitor devices.(b)(6) 2015: importer report number added.

• Brand Name: INSTRUMENT ESI STARTER KIT
• Type of Device: ENDO BASIC CLEANING 015
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; chemin de la vuarpilliere 31; nyon, 1260 ; SZ 1260
• Manufacturer Contact: virginie siloret ; chemin de la vuarpilliere 31; nyon, 1260 ; SZ 1260 ; 29944700
• MDR Report Key: 4401594
• MDR Text Key: 5126790
• Report Number: 3004096429-2014-00006
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1