MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRA SURGICAL HANDPIECE 3610N1; DENTAL SURGICAL HANDPIECE

Model Number 3610 N1

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 06/26/2020

Event Type  malfunction  

Manufacturer Narrative

The product was checked in the repair department at one of our dealers in france.The tests showed that the wear and tear of the product was still in specification.But there was also a lack of lubrication found, specially of the front bearing.This bearing could have a heavy load during surgical treatments and hence it could heat up if it is not maintained as specified in the ifu.Our local dealer sent a report to the clinic to point out the necessity of a suitable lubrication.

Event Description

During a dental surgical intervention the handpiece heated up and caused a burn in patients mouth.Further details have not been supplied.

• Brand Name: INTRA SURGICAL HANDPIECE 3610N1
• 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: 10295246
• MDR Text Key: 199480304
• Report Number: 3003637274-2020-00013
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K934783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3610 N1
• Device Catalogue Number: 0.524.5600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2017
• 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