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

Model Number 3610 N

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 02/15/2023

Event Type  malfunction  

Manufacturer Narrative

The customer denied to send the product back for analysis.Since the patient has sued the user, the user wants to withhold the instrument as evidence.The product is about 26 years old and gets not sold anymore since >20 years.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 caused a burn on patients inner cheek.Dentist denied to supply any further details.

• Brand Name: INTRA SURGICAL HANDPIECE 3610N
• 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: 17601512
• MDR Text Key: 321712125
• Report Number: 3003637274-2023-00021
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3610 N
• Device Catalogue Number: 0.524.5460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/1997
• 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