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

Model Number M8700 L

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2022

Event Type  malfunction  

Event Description

The dental office informed that during a dental treatment the bur came loose from the chuck of the handpiece.As the bur could not be found in the suction, it was assumed that the patient had swallowed it and x-rays were taken to verify this.However, the drill could not be found on the x-rays.This means that it was neither swallowed nor aspirated.No injury to patient and no medical care necessary.

Manufacturer Narrative

The analysis of the product showed that the retention force of the chuck system was too low.Hence the bur dropped out during the use.The test run prior to the repair showed also that the product was running out of specification with too low rpm.And bad running characteristics.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare and how to check the handpiece for each treatment and how to use it.2.3 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.Have parts with sites of breakage or surface changes checked by the service.If the following defects occur, stop working and have the service personnel carry out repair work: malfunctions, damage, irregular running noise, excessive vibration, overheating, and/or dental bur is not seated firmly in the handpiece.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 reprocessed and stored in a dry location, according to instructions, if it is not be used for a longer period.2.6 service and repair: repairs, servicing and safety checks may only be performed by trained service personnel.The following persons are authorized to do this: service technicians of kavo branches after the appropriate product training.Service technicians of kavo authorized dealers after the appropriate product training.Observe all the following items during servicing work: have the service and testing tasks carried out according to the medical device operator ordinance.After servicing, interventions on and repairs of the device and before re-use, have the service personnel perform safety checks on the device.Following expiry of the warranty, have the tool holding system checked once a year.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.As a result of the use of non-kavo original spare parts during the repair, parts such as covers may become undone and injure the patient, user or other people.This may result in aspiration, swallowing of parts and possibly even a risk of suffocation.Only use spare parts that comply with the specification for repair; original kavo spare parts comply with the specification.Note: if a repair is done with non-kavo original spare parts, this may constitute a product modification that leads to the loss of ce conformity.In the event of damage, the responsibility is with the service company or the operator.The introduction into the market of a modified product, where there is reasonable suspicion that the safety and health of patients or users may be jeopardized, is prohibited by the german medical device law §4, section 1 no.1 and requires a separate conformity check.5.4 inserting the dental bur: note: only use carbide cutters or diamond grinders that correspond to din en iso 1797 type 3, are made of steel or hard metal and meet the following criteria: shaft diameter: 1.59 to 1.60 mm (0.0626 in to 0.0629 in), overall length: max.25 mm, shaft clamping length: at least 11 mm, and blade diameter: max.2 mm (0.0787 in).Caution: defective clamping system.Risk of injury, dental bur may fall out during treatment.Pull on the dental bur to check if the clamping system works properly and if the dental bur is firmly clamped.

• 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
• Manufacturer (Section G): KAVO DENTAL GMBH; bismarckring 39; biberach / riss, 88400 ; GM 88400
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach / riss, 88400 ; GM 88400
• MDR Report Key: 15678544
• MDR Text Key: 303243191
• Report Number: 3003637274-2022-00035
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/27/2022

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: M8700 L
• Device Catalogue Number: 3.001.0000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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