MAUDE Adverse Event Report: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. SCALAR SYSTEM TIP, PERIODONTIC, ULTRASONIC; ENDOCHUCK

Device Problems Break (1069); Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: SCALAR SYSTEM TIP, PERIODONTIC, ULTRASONIC
• Type of Device: ENDOCHUCK
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; chemin de la vuarpilliere 31; nyon 1260 ; SZ 1260
• Manufacturer Contact: siloret virginie ; chemin de la vuarpilliere 31; nyon 1260 ; SZ 1260 ; 1229944700
• MDR Report Key: 4658383
• MDR Text Key: 5679670
• Report Number: 3004096429-2015-00002
• Device Sequence Number: 1
• Product Code: EMN
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other