MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRA SURGICAL HANDPIECE 3554; DENTAL SURGICAL HANDPIECE

Model Number 3554

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

The root cause analysis showed that the bearings have been stiff, grinding, vibrating and coming apart.This is the result of the normal wear process.To avoid such incidents the ifu contains notes and warnings for the correct handling and use of 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.Caution: heating of the product.Burns or product damage from overheating.Do not use the product if it is irregularly heated.The medical device is too hot while working: service the medical device.

Event Description

During the treatment on (b)(6) 2017 the handpiece heated up and caused a burn on lower right cheek.The patient is female age (b)(6) years old.A medical care was not necessary and the burn healed fully meanwhile.

• Brand Name: INTRA SURGICAL HANDPIECE 3554
• 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, bw 88400 ; GM 88400 ; 735156
• MDR Report Key: 6559576
• MDR Text Key: 74887326
• Report Number: 3003637274-2017-00029
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K934783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Model Number: 3554
• Device Catalogue Number: 0.524.5440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/1996
• 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 Age: 17 YR