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

Model Number 3610N1

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 08/12/2014

Event Type  Injury  

Event Description

During a dental surgical treatment on tooth #17 the handpiece heated up and caused a burn on lower lip and tongue.The lip split and doctor put in sutures/stitches to close it.The doctor prescribed viscous lidocaine topical ointment.

Manufacturer Narrative

The analysis did show that the handpiece had rusty looking residue inside and a high debris level.It did also show that the bearings have been vibrating, grinding and heating up.The handpiece has not been repaired since (b)(4) 2011.The residue and the debris indicate that the handpiece was not maintained as requested in the user instruction.This caused higher friction in the bearings and finally the heat up of the bearing and the head.(b)(4).

• Brand Name: INTRA SURGICAL HANDPIECE 3610N1
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bahnhofstrasse 20; warthausen 8844 7; GM 88447
• Manufacturer Contact: klaus reisenauer ; bismarckring 39; biberach 88400 ; GM 88400 ; 351561356
• MDR Report Key: 4169420
• MDR Text Key: 4872720
• Report Number: 3003637274-2014-00030
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073478
• 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: 08/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3610N1
• Device Catalogue Number: 0.524.5600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2014
• Distributor Facility Aware Date: 08/25/2014
• Event Location: Other
• Date Report to Manufacturer: 08/25/2014
• Initial Date Manufacturer Received: 08/25/2014
• Initial Date FDA Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2009
• 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
• Patient Age: 13 MO