MAUDE Adverse Event Report: E.M.S. ELECTRO MEDICAL SYSTEMS S.A. KIT PIEZON LED HEKA

Model Number FS-371#A

Device Problems Melted (1385); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

A dentist has a no pain with led, which gets so hot that it "burns/melts" through the rubber glove and on the pts cheek.

Manufacturer Narrative

We suppose that the en-060/a handpiece is defective.This could be related to a wrong reprocessing process at the user, however, we need to assess it to confirm this hypothesis.We did not know the serial number of this handpiece, but it was replaced the (b)(6) by our after sale svc.Despite two reminders the 09th and the 20th february, we have not rec'd any add'l info for the time being.

• Brand Name: KIT PIEZON LED HEKA
• Type of Device: KIT PIEZON LED HEKA
• Manufacturer (Section D): E.M.S. ELECTRO MEDICAL SYSTEMS S.A.; chemin de la vuarpolliere 31; nyon 1260 ; SZ 1260
• Manufacturer Contact: virginie siloret ; chemin de la vuarpillere 31; nyon 1260 ; 1229944700
• MDR Report Key: 4637918
• MDR Text Key: 5759329
• Report Number: 3004096429-2015-00001
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FS-371#A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/27/2015
• Initial Date FDA Received: 02/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other