MAUDE Adverse Event Report: W & H DENTALWERK BUERMOOS GMBH S-11 LED G; SURGICAL HANDPIECE, 76 KMW

Model Number S-11 LED G

Device Problems Device Maintenance Issue (1379); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problems Injury (2348); Full thickness (Third Degree) Burn (2696)

Event Date 07/22/2014

Event Type  Injury  

Event Description

In the course of a dental treatment the dentist used a w&h s-11 led g.During the removal of four wisdom teeth the pt suffered a three degree burn on the right corner of the mouth because the instrument got hot.At the beginning of the treatment the pt got a local anesthetics therefore she did not feel anything.The pt has not further diseases which could have affect on the healing process.The dentist prescribed panthenol.

Manufacturer Narrative

We, w&h as the manufacturer, received the concerned instrument in august 2014 for repair.At that time, we got no info that an injury or other adverse event has happened.After a detailed analysis by our service techs, we found out, that the instrument was very polluted.We have also informed the dentist about this fact.Therefore, it was not a product problem because the practicing dentist has maintained the instrument very poorly and not in compliance with w&h's instructions for use.The specs for hygiene and maintenance are clearly stated in w&h's ifu (surgical handpiece s-11 led g) on pages 20-32.

• Brand Name: S-11 LED G
• Type of Device: SURGICAL HANDPIECE, 76 KMW
• Manufacturer (Section D): W & H DENTALWERK BUERMOOS GMBH; buermoos 5111 ; AU 5111
• Manufacturer Contact: ignaz-glaser-strasse 53; buermoos 5111 ; 2746236397
• MDR Report Key: 4660246
• MDR Text Key: 16177988
• Report Number: 9681479-2015-00002
• Device Sequence Number: 1
• Product Code: KMW
• Combination Product (y/n): N
• PMA/PMN Number: K080939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S-11 LED G
• Device Catalogue Number: 00001130
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2010
• 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 Outcome(s): Other