MAUDE Adverse Event Report: KAVO DENTAL GMBH INTRA HANDPIECE CL10; DENTAL HANDPIECE

Model Number CL10

Device Problems Overheating of Device (1437); Physical Resistance/Sticking (4012)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation prior to the repair showed that the ball bearing at the front of the chuck was so worn out that it was already falling apart.This caused high friction and hence heat up of the device.The product history showed that the instrument was not sent in for maintenance / repair since 11 years.Depending on frequency of use a regular check up of the product at a licensed repair shop is recommended.The instruction for use requests a functional and visual check of the product prior to each treatment.

Event Description

The patient had all four impacted wisdom teeth removed during one surgical session.The procedure was initially unremarkable.During suturing the wound after removing tooth # 48, extensive burns of the lower lip on the right side (lip red), and of the intraoral mucosa in the vestibule on the right with superficial blistering were noticed.The entire treatment was consistently cooled with sterile irrigation solution.The wounds have been treated with greasy-moist bandages as well as constant cooling.The wound healing was subsequently medically monitored.Scar-free healing cannot be predicted with certainty at this point in time.

• Brand Name: INTRA HANDPIECE CL10
• 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: 10913161
• MDR Text Key: 218574778
• Report Number: 3003637274-2020-00021
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K934791
• 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: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CL10
• Device Catalogue Number: 1.002.0911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2007
• 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: 16 YR