MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRA SURGICAL HANDPIECE 3610N2; DENTAL SURGICAL HANDPIECE

Model Number 3610 N2

Device Problems Overheating of Device (1437); Physical Resistance/Sticking (4012)

Patient Problem Burn, Thermal (2530)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

The analysis of the product prior to the repair showed that the heat up was reproducible during the test run.After disassembling it got visible that there was residue inside the handpiece.This caused higher friction and hence heat up.It got also noticeable that the ball bearings have been worn out.This caused also higher friction and hence heat up of the product.To avoid such incidents the instruction for use contains already notes and warnings how to prepare and use the product: 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.To ensure proper function, the medical device must be set up according to the reprocessing methods described in the kavo instructions for use, and the care products and care systems described therein must be used.Kavo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device.This service interval depends on the frequency of use and should be adjusted accordingly.Service may only be carried out by kavo-trained repair shops using original kavo replacement parts.Caution: heating of the product.Burns or product damage from overheating.Do not use the product if it is irregularly heated.Proper use: according to these regulations, this medical device may only be used for the described application by a knowledgeable user.The following must be observed: the applicable health and safety regulations.The applicable accident prevention regulations.These instructions for use.According to these regulations, it is the responsibility of the user to: only use equipment that is operating correctly, use the equipment for the proper purpose, protect him or herself, the patient and third parties from danger, and avoid contamination from the product.

Event Description

During a dental surgical treatment the front end of the handpiece got hot and caused a burn on patients oral mucosa.Further details have not been supplied.

• Brand Name: INTRA SURGICAL HANDPIECE 3610N2
• Type of Device: DENTAL SURGICAL 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, 88400 ; GM 88400
• MDR Report Key: 8518228
• MDR Text Key: 151739140
• Report Number: 3003637274-2019-00015
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K934783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3610 N2
• Device Catalogue Number: 0.524.5610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2010
• 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: 23 YR