MAUDE Adverse Event Report: KAVO DENTAL GMBH BELLATORQUE LUX MULTIFLEX TURBINE 645 B; DENTAL HANDPIECE

Model Number 645 B

Device Problem Failure To Service (1563)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

The analysis of the product did show that it has been produced and delivered in 02/1997.Since that time it was never sent in for a service/ repair/ check! the product has many small nicks spread over the whole head of the instrument.This shows that it received over the last 18 years hits from the environment.Such hits cause that the screw connection of the back cap button gets unlocked.Due to the vibration of the treatment it gets slowly unscrewed until it drops off.As there was no maintenance of the handpiece it was not recognized that the back cap was unlocked.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment: 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.A typical service interval would be annual or bi-annual.The ifu requests also that prior to each treatment the product gets checked visually and functionally.Incident occured in (b)(6) and is reported to fda as similar products get distributed in the us.

Event Description

Described is that during a standard dental treatment the back cap of the handpiece fell into patients mouth.Patient swallowed the part.No medical care necessary.No further data have been supplied by the dental office.

• Brand Name: BELLATORQUE LUX MULTIFLEX TURBINE 645 B
• 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: 5572681
• MDR Text Key: 42505909
• Report Number: 3003637274-2016-00024
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dental Assistant
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 645 B
• Device Catalogue Number: 0.553.2050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/1997
• 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