MAUDE Adverse Event Report: KAVO DENTAL GMBH SMARTTORQUE MINI LUX S615 L; DENTAL HANDPIECE

Model Number S615 L

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

During the visual and functional inspection prior to the repair it was already noticeable that the retention force of the chuck system was too low and hence the burs have not been held correctly.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 * 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.Caution: defective clamping system.Risk of injury, dental bur may fall out during treatment.->pull on the dental bur to check if the clamping system works properly and if the dental bur is firmly clamped.

Event Description

During crown preparation on tooth 19, the drill flew off the instrument.The drill was neither on the patient nor on the floor, so it was assumed that the drill could have been swallowed.The patient then stated that she felt something in her throat and could not get it out.Staff walked the patient to affinity's emergency department for an x-ray.The bur was found in the upper gastrointestinal tract.Patient came back into dental office on (b)(6) 2023 to finish crown preparation.

• Brand Name: SMARTTORQUE MINI LUX S615 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: 18709717
• MDR Text Key: 336515367
• Report Number: 3003637274-2024-00004
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/15/2024

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: S615 L
• Device Catalogue Number: 1.008.1643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2022
• 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