MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTTORQUE S608 C; DENTAL HANDPIECE

Model Number S608 C

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/21/2017

Event Type  malfunction  

Manufacturer Narrative

It was promised by the local dealer that the product in question will be sent back for analysis.Unfortunately it was not possible to get the product, yet.We will send a follow-up-report once we have been able to get and analyze the product.Not returned for analysis, yet.

Event Description

During a standard dental treatment the back cap of the turbine came loose in patient's mouth and was swallowed by him.There is no further information supplied.

Manufacturer Narrative

The product was finally received from (b)(6) and evaluated by r&d.All measurements have been found within specification.The head of the instrument did not show any signs of harsh handling, e.G.Dents, scratches etc.Unfortunately the swallowed part was not included in the shipment, hence it was not available for analysis.Therefore there are some scenario possible why the back cap came loose but it is not possible to clearly identify a root cause.Independent to the result of the root cause analysis the ifu contains already notes and warnings how to prepare and use the product: 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.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.

• Brand Name: SMARTTORQUE S608 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, bw 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, bw 88400 ; GM 88400 ; 735156
• MDR Report Key: 6607399
• MDR Text Key: 76527051
• Report Number: 3003637274-2017-00035
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K093341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: S608 C
• Device Catalogue Number: 3.001.6560
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• 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