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

Model Number M8900 L

Device Problem Misassembly by Users (3133)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/15/2019

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.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

Dental office was not able to recall patient name to pull file for details, hence just the information that could be recalled have been supplied.During dental treatment the bur got detached from handpiece and was swallowed by patient.Patient was sent to have an x-ray to ensure position of the bur.The bur passed the patient on natural way without causing any issues.Reported as serious injury as taking an x-ray is defined as medical care.

• Brand Name: MASTERTORQUE LUX M8900 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: 8690994
• MDR Text Key: 147715138
• Report Number: 3003637274-2019-00024
• 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 faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M8900 L
• Device Catalogue Number: 1.008.7800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2019
• Distributor Facility Aware Date: 05/17/2019
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 05/17/2019
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2015
• 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 Outcome(s): Other