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 04/07/2017

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: 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 burr 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.(b)(4).

Event Description

Dr.(b)(6) said approximately on (b)(6) 2017 halfway through a tooth extraction, the burr started to become wobbly.He removed the handpiece from patient mouth and tested it in his hand.The handpiece then become very hot and caused his right ring finger and pointer finger to be burned.Each burn was dime in size.He said they looked like a red sun burns that lasted 1 day.He applied aloe vera lotion to his fingers.Doctor is male age (b)(6).No medical care necessary.

• 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: 6551302
• MDR Text Key: 74629708
• Report Number: 3003637274-2017-00028
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K934783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2017
• 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: 04/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2003
• 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: 37 YR