MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERTORQUE LUX M9000 L COLOR; DENTAL HANDPIECE

Model Number M9000 L

Device Problem Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/09/2019

Event Type  malfunction  

Manufacturer Narrative

The handpiece was not sent back to (b)(6) for analysis but was checked locally at the manufacturers subsidiary in (b)(6).It was tested according to the valid specification.Especially the retention force of the chucking system.There was no deviation found.If the tool shank diameter and length corresponds with the specified values, all parameters are ok.No fault was detectable at the product.Checking the used bur showed that it did not match with the requested specifications.The shaft of the bur was only 8.5mm long, the ifu requests at least 11mm.This results in a lower retention force and explains why the bur came loose during the treatment.The tools which get used are in general third party products and get chosen by the user.To ensure that they fulfill the necessary specification and that they get used and inserted in the correct way, the instruction for use contains several notes and warnings.2.3 accessories and combination with other equipment use of un-authorised accessories or un-authorised modifications of the device could lead to injury.Only use accessories that have been approved for combination with the product by the manufacturer.Only use accessories that are equipped with standardised interfaces.5.4 inserting the milling tools or diamond grinders note: only use carbide cutters or diamond grinders that comply with en 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: at least 9 mm.Blade diameter: max.2 mm.Warning: use of unauthorised dental burs or diamond grinders.Injury to the patient or damage to the medical device.Comply with the instructions for use and use the dental bur or diamond grinder properly.Only use dental burs or diamond grinders that do not deviate from the specified data.Caution: use of dental burs or diamond grinders with worn or damaged shafts.Risk of injury, tool may fall out during treatment.Never use dental burs or diamond grinders with damaged or worn shafts.Caution: hazard from defective chuck system.The cutter or grinder could fall out and cause injury.Pull on the dental burr or rips abrasives to check if the clamping system is functioning properly and that the tool is firmly clamped.Wear gloves or a thimble to check, insert, or remove the bits to prevent injury and infection.Incident is reported as a similar product gets distributed in the usa.

Event Description

During standard dental treatment the bur came loose and fell into patient's mouth.Patient swallowed the bur.To confirm location of the bur she was sent to hospital to take some x-rays.It was confirmed that the bur was in the stomach.It was decided to remove the bur via an endoscopic intervention.Patient visited the dental office again on (b)(6) 2019 and was doing fine.

• Brand Name: MASTERTORQUE LUX M9000 L COLOR
• 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
• MDR Report Key: 8309811
• MDR Text Key: 135161944
• Report Number: 3003637274-2019-00008
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/06/2019

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: M9000 L
• Device Catalogue Number: 1.007.9900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2019
• Initial Date FDA Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2018
• 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 Age: 40 YR