MAUDE Adverse Event Report: KAVO DENTAL GMBH SURGMATIC S11 L; DENTAL HANDPIECE

Model Number S11 L

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

Patient Problem Burn(s) (1757)

Event Date 01/30/2023

Event Type  malfunction  

Event Description

During a wisdom tooth extraction, the dentist noticed that the handpiece was getting warm in his hand.When he removed the handpiece from patient's mouth he saw that the lip was red and irritated where the handpiece touched the skin.The handpiece was switched out and the procedure was completed.The doctor applied some otc vaseline to the affected area as a precautionary measure and no further medical care was required.At the post surgery follow up, the dentist notes that the lip healed without any issue.

Manufacturer Narrative

During the visual and functional inspection prior to the repair, it was already noticeable that the handpiece was running out of specification.The bearings have been grinding and vibrating and due to the bad condition of the bearings the heat up of the front end of the handpiece was reproducible.As the handpiece was only in use for a few months since the last repair it is very likely that the root cause for the defect is that the reprocessing is not done according to ifu.To avoid such issues the user instruction contains already several notes, warnings and requests how to prepare the handpiece for each treatment and how to use it: 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, and 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 , or tool is not seated firmly 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.Define the service interval depending on the frequency of use.

• Brand Name: SURGMATIC S11 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: 16452207
• MDR Text Key: 310335529
• Report Number: 3003637274-2023-00002
• Device Sequence Number: 1
• Product Code: EFA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/28/2023

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: S11 L
• Device Catalogue Number: 1.009.1010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2018
• 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