MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRACOMPACT 25LCR; DENTAL HANDPIECE

Model Number 25LCR

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

Patient Problem Burn(s) (1757)

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

During the visual and functional inspection prior to the repair it was already noticeable that the handpiece was running out of specification.It was running slow and the heat up of the head was reproducible, which indicates that there was higher friction inside.After disassembling it got visible that the product was clean inside which shows that the reprocessing is done correctly.But the ball bearings have been worn out.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment and how to use it: 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.Have parts with sites of breakage or surface changes checked by the service.If the following defects occur, stop working and have the service personnel carry out repair work: malfunctions, damage, irregular running noise, excessive vibration, overheating.Tool is not seated firmly in the handpiece.Following expiry of the warranty, have the tool holding system checked once a year.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 filling procedure to tooth #31 dentist felt heat and pulled the handpiece away.He saw a burn on inner right cheek and rinsed it directly with periogard to disinfect.Patient has been called on 03/20/2023 to ensure that he is doing fine, which he confirmed.No medical care necessary.

• Brand Name: INTRACOMPACT 25LCR
• Type of Device: DENTAL 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: 16712057
• MDR Text Key: 313021140
• Report Number: 3003637274-2023-00006
• Device Sequence Number: 1
• Product Code: EFA
• 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: User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/11/2023

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: 25LCR
• Device Catalogue Number: 1.007.5700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2010
• 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