MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTTORQUE S609 C; DENTAL HANDPIECE

Model Number S609 C

Device Problems Overheating of Device (1437); Dent in Material (2526); Physical Resistance/Sticking (4012)

Patient Problem Burn, Thermal (2530)

Event Date 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

A quick visual inspection prior to the repair showed already that the product had a dent at the back cap which caused the push button to stick in.Such a dent is the result of a strong external hit, e.G.A drop of the product and causes high inner friction and hence heat up.The functional test showed that the tool holder system was worn out causing a too low retention force of the bur.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment and how to use it: warning: hazards for the care provider and the patient.In the case of damage, irregular running noise, excessive vibration, untypical warming or when the cutter or grinder cannot be held.Do not use further and notify service.Caution: burning hazard from hot instrument head or hot instruments cover.If the instrument overheats, burns may arise in the oral area.Never contact soft tissue with the instrument head or instrument cover note: for safety reasons, we recommend that the tool holder system be checked annually after the warranty period expires.To ensure proper function, the medical device must be set up according to the reprocessing methods described in the kavo instructions for use, and the care products and care systems described therein must be used.Kavo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device.This service interval depends on the frequency of use and should be adjusted accordingly.Indications for use: this medical device is: intended for dental treatment only.All other types of use or modifications of the product are not permitted and can be hazardous.The medical device is intended for the following applications: removal of carious material, cavity and crown preparations, removal of fillings, processing of tooth and restoration surfaces.A medical device according to relevant national statutory regulations.Proper use: according to these regulations, this medical device may only be used for the described application by a knowledgeable user.You need to comply with the following: the applicable health and safety regulations.The applicable accident prevention regulations.These instructions for use.According to these regulations, the user is required to: only use equipment that is operating correctly, adhere to the specified intended use protect him or herself, the patient and third parties from danger, and avoid contamination from the product.(b)(4).

Event Description

The dental office just informed that a patient has been burned during a treatment.User denied to supply further details.Hence 'day of event' is best estimate and patient data are blank.

• Brand Name: SMARTTORQUE S609 C
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, bw 88400 ; GM 88400
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 8564395
• MDR Text Key: 143564838
• Report Number: 3003637274-2019-00017
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S609 C
• Device Catalogue Number: 1.008.1644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• 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