MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRA SURGICAL HANDPIECE 3610N2; DENTAL SURGICAL HANDPIECE

Model Number 3610 N2

Device Problems Mechanical Problem (1384); Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 08/10/2021

Event Type  malfunction  

Manufacturer Narrative

Prior to the repair the instrument has been checked visually and functionally.Visually there have been no deviations from outside.After removing the grip sleeve, which has to be done also by the user for the reprocessing after use, it got visible that also the inner side was in a good overall condition.There was only minor residue in the front end of the sleeve.But the first check by hand of the front bearings showed that the small bearing was worn out running rough and the bigger bearing was almost jammed.It was hard to turn it by hand.The functional test run then showed that the handpiece got hot within a few seconds without any load.Root cause for the heat up is in the end high friction of the worn-out ball bearings.To avoid such issues the instruction for use contains already several warnings and notes how to prepare and use the product: 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 caused a burn on patients inner cheek.Further details have not been supplied.

• Brand Name: INTRA SURGICAL HANDPIECE 3610N2
• 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: 12664395
• MDR Text Key: 277358541
• Report Number: 3003637274-2021-00037
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 10/20/2021

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 N2
• Device Catalogue Number: 0.524.5610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2021
• Initial Date FDA Received: 10/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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