MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTTORQUE LUX S619 L; DENTAL HANDPIECE

Model Number S619 L

Device Problems Dent in Material (2526); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

During the visual and functional inspection prior to the repair it was already noticeable that the head had several dents which shows that the product received several strong external hits, e.G.By dropping down.Such a hit causes that the back cap gets unlocked and could get unscrewed if product gets used further.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: 2.2 technical condition: a damaged device or components could injure patients, users and third parties.Only operate devices or components if they are undamaged on the outside.Check that the device is working properly and is in satisfactory condition before each use.Have parts with sites of breakage or surface changes checked by the service.If the following defects occur, stop working and have the service personnel carry out repair work: malfunctions ,damage , irregular running noise ,excessive vibration ,overheating ,and tool is not seated firmly in the handpiece.Following expiry of the warranty, have the tool holding system checked once a year.Kavo recommends specifying in-house service intervals where the medical device is brought to a professional shop for cleaning, servicing and a function check.Define the service interval depending on the frequency of use.

Event Description

The dental dealer just informed that the back cap of the handpiece fell off in patients mouth who swallowed it.Further information, which we requested, have not been supplied.Date of event is best estimate.

• Brand Name: SMARTTORQUE LUX S619 L
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 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: 13948110
• MDR Text Key: 288172330
• Report Number: 3003637274-2022-00015
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K093341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S619 L
• Device Catalogue Number: 1.008.1641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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