MAUDE Adverse Event Report: KAVO DENTAL GMBH KAVO GENTLEMINI LUX 4500BR; DENTAL HANDPIECE

Model Number 4500 BR

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

Product is currently at dental dealer and is planned to be sent back to kavo dental for analysis.Once available follow-up- or final - report will be supplied.

Event Description

Description as supplied by dental dealer: patient thought that she swallowed the 330 brassler bur.Patient was advised to go to emergency room on site.Patient had a chest x-ray and ct scan, neither of which indicated that she actually swallowed the bur.Patient was discharged in good condition.

Manufacturer Narrative

The handpiece was returned and analyzed / tested to determine if the product was within specification.It was determined during the evaluation that a non-certified third-party turbine / chuck was assembled in the handpiece.The test of the chuck showed that the retention force was too low which is the reason why the bur was lost during the treatment.As the chuck underlies a wear process it is normal that it needs to be exchanged from time to time.The ifu (instruction for use) requests therefore that the handpiece should be tested regularly depending on the frequency of use and that the proper seat of the tool should be tested prior to each treatment.Additionally, the handpiece has not been returned to kavo for servicing until now, since being sold in 2010.As customer did not supply information about the service history, we are not aware of the product history during this 10 years.The ifu contains already following notes and warnings to avoid such events: 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.Service may only be carried out by kavo-trained repair shops using original kavo replacement parts.The following individuals are authorized to repair and service kavo products: technicians at kavo branches throughout the world.Technicians specially trained by kavo.

• Brand Name: KAVO GENTLEMINI LUX 4500BR
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 10513611
• MDR Text Key: 206545297
• Report Number: 3003637274-2020-00017
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4500 BR
• Device Catalogue Number: 1.007.1700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Date Manufacturer Received: 08/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR