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(s) (1757)

Event Date 03/28/2024

Event Type  malfunction  

Manufacturer Narrative

The instrument has been checked against the valid specification.During the visual inspection, it became immediately apparent that the grip sleeve had an out-of-round gap on the front side around the tool holder, which is not intended here.The root cause for this was that the front bearing was completely worn out and hence the deflector tip of the tool holder was rubbing on the grip sleeve while the instrument was in use.This unusual friction caused the tip to heat up.After disassembling of the handpiece, it was found that all ball bearings have been completely worn out and running rough.In addition, it was found that inside the instrument a lot of baked-in protein residues have been present which causes quick and strong wear of the ball bearings.This shows clearly that the instrument in not reprocessed and maintained as requested by the ifu.To avoid such issues the instruction for use contains already several warnings and notes how to prepare and use the product: 2.2 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 broken or damaged parts or clearly visible 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 running noise excessive vibration overheating dental bur or diamond grinder are not firmly locked in the handpiece 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.

Event Description

During a dental surgical intervention, the handpiece heated up and burned the patient.Dentist denied to supply any further details.Date of event is best extimate as customer did not supply the information.

• Brand Name: INTRA SURGICAL HANDPIECE 3610N1
• Type of Device: DENTAL SURGICAL 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: 19123900
• MDR Text Key: 340353526
• Report Number: 3003637274-2024-00011
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 04/05/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2014
• 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