MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERTORQUE MINI LUX M8700 L; DENTAL HANDPIECE

Model Number M8700 L

Device Problem Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/01/2019

Event Type  Injury  

Manufacturer Narrative

The visual and functional inspection prior to the repair showed that the chuck was worn out, hence it was not able to hold the tool (bur) in position and the running performance was low.This is the result of normal wear process.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: 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.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.If there are any sites of breakage or clearly recognised changes on the surface, the parts must be checked by the service.Safety checks may only be performed by trained service personnel.If the following defects occur, stop working and have the service personnel carry out repair work: malfunctions.Damage.Irregular noise.Excessive vibration.Untypical heating.No firm seating of the grinder or cutter in the instrument.Observe the following instructions in order to guarantee optimum functioning and prevent material damage: service the medical device with care products and systems regularly as described in the instructions for use.The device should be cleaned, serviced and stored in a dry location, according to instructions, if it will not be used for a longer period.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.(b)(4).

Event Description

During a direct resin restoration to tooth #18 the bur separated from instrument, fell into patient's mouth and was swallowed by him.This did not cause any injury to the patient, just a 'scratchy throat' according to dentist.Patient went to emergency room of hospital to have a chest and abdominal, lateral neck x-ray in order to ensure that bur was swallowed and not aspirated.The doctor of the emergency room detected the bur in the stomach of the patient and informed that it should pass without incident.Patient was followed up the following week without any complaints or discomfort.

Manufacturer Narrative

By mistake the importer# 1017522-2019-00017 has been used twice.Therefore with this report the number gets corrected to 1017522-2019-00018.Exemption number e2010020 kavo dental gmbh germany (the manufacturer) is submitting the report on behalf of kavo dental usa (the importer).

• Brand Name: MASTERTORQUE MINI LUX M8700 L
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 9415531
• MDR Text Key: 169213170
• Report Number: 3003637274-2019-00041
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K130560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/05/2019,12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8700 L
• Device Catalogue Number: 3.001.0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2019
• Distributor Facility Aware Date: 11/07/2019
• Device Age: 2 YR
• Event Location: Other
• Date Report to Manufacturer: 11/07/2019
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 80 YR