MAUDE Adverse Event Report: KAVO DENTAL GMBH EXPERTTORQUE LUX E679 L; DENTAL HANDPIECE

Model Number E679 L

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

The visual and functional check prior to the repair showed that the product was in a good overall condition.The inspection just showed that the back cap was missing, no signs of external force have been visible on the shell.The threads on the head have been in good condition.As the back cap was not available, hence it was not possible to check it for signs of wear or external forces which would explain why the back cap was unlocked.To avoid such issues the instruction for use contains already several warnings and notes: 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.Have parts with sites of breakage, or surface changes checked by the service.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 is not firmly locked in the handpiece.Following expiry of the warranty, have the tool holding system checked once a year.Kavo recommends specifying in-house service intervals where the medical device is brought to a professional shop for cleaning, servicing and a function check.Defined the service interval depending on the frequency of use.

Event Description

During a standard dental procedure on tooth #19 the back cap of the handpiece became loose, and fell into patients mouth.Part was swallowed by patient.Patient was ok, and he was to keep practice informed of any issues.No injury to patient, and no medical care necessary.

• Brand Name: EXPERTTORQUE LUX E679 L
• Type of Device: DENTAL 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: 10748723
• MDR Text Key: 213889862
• Report Number: 3003637274-2020-00018
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073478
• 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: 10/28/2020

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: E679 L
• Device Catalogue Number: 1.006.9200
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• 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: 59 YR