MAUDE Adverse Event Report: KAVO DENTAL GMBH MIRA LUX MULTIFLEX TURBINE 635 B; DENTAL HANDPIECE

Model Number 635B

Device Problem Failure To Service (1563)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/31/2016

Event Type  Injury  

Manufacturer Narrative

The analysis of the handpiece showed that the front bearing had heavy residue.The push button stuck in and the inner portion of push button was worn down.The bur slipped and the chuck system failed the retention test.Last repair of the handpiece was 06/23/2009! all findings show that the handpiece should not have been used anymore due to advanced wear process at several important components.This is absolutely normal after the very long period in use.Kavo therefore requests that the products get sent in on a regular base for professional check/repair.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment: 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.Note: for safety reasons, we recommend that the tool holder system be checked annually after the warranty period expires.The following individuals are authorized to repair and service kavo products: *technicians at kavo branches throughout the world.* technicians specially trained by kavo.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.Insert the milling cutters or diamond grinders.Note: only use carbide cutters or diamond grinders that correspond to iso 1797-1 type 3, are made of steel or hard metal and meet the following criteria: - shaft diameter: 1.59 to 1.60 mm, - overall length: max.21 mm, - shaft clamping length: min.9 mm, - blade diameter: max.2 mm.Warning: use of unauthorised cutters or grinders.Injury to the patient or damage to the medical device.- observe the instructions for use and use the cutter or grinder properly.- only use cutters or grinders that do not deviate from the specified data.Caution: injury from using worn drill bits or burs.Drill bits or burs could fall out during treatment and injure the patient.- never use drill bits or burs with worn shafts.Caution: hazard from defective chucking system.The cutter or grinder could fall out and cause injury.- pull on the cutter or grinder to check that the chucking system is okay and the cutter or grinder is securely held.When checking, inserting and removing, use gloves or a fingerstall to prevent an injury or infection.(b)(4).

Event Description

Dr.(b)(6) said on (b)(6) 2016 while working on tooth# 9, the bur came loose in mouth.He tried to remove the bur with forceps, but patient swallowed it before he could.He referred her to see her normal physician dr.(b)(6) to have an x-ray and to make sure if passed without any issue.Dr.Williams however wanted the bur removed.Patient was put to sleep while a surgeon retrieved the bur going through mouth down throat.The patient since then had called dr.(b)(6) and said she was not in any discomfort.

• Brand Name: MIRA LUX MULTIFLEX TURBINE 635 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: 6127175
• MDR Text Key: 60855405
• Report Number: 3003637274-2016-00067
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/25/2016,10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 635B
• Device Catalogue Number: 0.553.2220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2016
• Distributor Facility Aware Date: 10/31/2016
• Device Age: 11 YR
• Event Location: Other
• Date Report to Manufacturer: 10/31/2016
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2005
• 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
• Patient Outcome(s): Other
• Patient Age: 57 YR