MAUDE Adverse Event Report: KAVO DENTAL GMBH SUPERTORQUE LUX TURBINE 660B; DENTAL HANDPIECE

Model Number 660B

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2014

Event Type  malfunction  

Event Description

During a standard dental treatment the spray plat of the handpiece became loose and fell apart.It was swallowed by the patient.There was no injury to a person.The plate ran through the gastrointestinal passage and left the patient with normal defecation.Unfortunately there are no details about the patients age or gender supplied.

Manufacturer Narrative

The product was not returned to the manufacturer for analysis, but it was sent to the local dealer in new zealand for repair.There it was detected that the bearings of the head have been worn out this caused a wobbling of the bur and therefore strong vibrations.This vibrations caused that the nut of the spray plate became loose and finally fell off.The condition of the bearings is due to normal process.The user instruction requires following procedures to avoid such issues: caution: injury or damage due to wear.Irregular running noise, significant vibration, overheating, imbalance or insufficient grip - stop work and see service support.Kavo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device.This service interval should take into account the frequency of use.Reported due to the 2 year presumption rule.

• Brand Name: SUPERTORQUE LUX TURBINE 660B
• Type of Device: DENTAL HANDPIECE
• Manufacturer (Section D): KAVO DENTAL GMBH; bahnhofstrasse 20; warthausen 8844 7; GM 88447
• Manufacturer Contact: klaus reisenauer ; bismarkring 39; biberach 88400 ; GM 88400 ; 351561356
• MDR Report Key: 4272135
• MDR Text Key: 5028852
• Report Number: 3003637274-2014-00036
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K073478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 10/22/2014

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: 660B
• Device Catalogue Number: 1.002.2200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2011
• 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