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 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

The overall condition of the product is quite good - it shows some discoloration on the outside of the sleeve and at the cone at the front side internally.This is a sign of burned-in tissue residue and/or residue of used cleaning/ disinfection ingredients.It does not interfere with the function.But it could be a sign that the reprocessing is not performed as requested by the ifu which could cause stronger wear.A first visual check showed that the bearings start to run gritty which is a sign of wear - normal if a product gets used for 20 months.It was not possible to re-produce any heat up of the product during the test run, even with a very high load.It got not warmer than lukewarm.The only noticeable deviation was the sound of the bearings and a slightly too high power consumption - which correlates with the diagnosis of the visual check.

Event Description

During a dental apical resection, at the time of milling, the handpiece heated up and burned the patient to the upper left lip.Further details have not been supplied, hence the 'date of event' is best estimate.

• 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: 8259991
• MDR Text Key: 133528166
• Report Number: 3003637274-2019-00005
• 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: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: No
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2017
• 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