MAUDE Adverse Event Report: KAVO DENTAL GMBH MASTERTORQUE LUX M8900 L; DENTAL HANDPIECE

Model Number M8900 L

Device Problem Failure To Service (1563)

Patient Problem Laceration(s) (1946)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

The inspection prior to the repair showed that the chuck was worn out, the bearings have been falling apart and inside the handpiece was heavy residue.The residue is the result of wear which gets normally removed out of the handpiece if it gets cleaned, sterilized and reprocessed as requested in the ifu.If this is not correctly done, residue keeps i the handpiece and hence also in the bearings which causes stronger wear and soon wobbling of the tool and it is running noisy.The stronger vibration could cause that the looked back cap gets unlocked and slowly unscrewed.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.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.Defined the service interval depending on the frequency of use.

Event Description

During a dental treatment the head of the handpiece came apart in patients mouth.All parts have been retrieved but when the handpiece came apart a diamond bur was in use which caused a very small cut in patients left cheek.No medical care was necessary for this cut.Dental office does not recall name of patient hence the supplied data are best estimate.

• Brand Name: MASTERTORQUE LUX M8900 L
• 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: 6875538
• MDR Text Key: 87339937
• Report Number: 3003637274-2017-00058
• 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
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 09/19/2017

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: Dentist
• Device Model Number: M8900 L
• Device Catalogue Number: 1.008.7800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2015
• 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
• Patient Age: 55 YR