MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH S-12; SURGICAL HANDPIECE

Model Number	S-12
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The handpiece was analysed in w&h service station.There were no damages identified.It functions accordingly during the test procedure.
Event or Problem Description
The end-user stated that the tip of the handpiece s-12 got hot and burned the patient.Also the assistant got burn marks after touching the handpiece.

• Brand Name: S-12
• Common Device Name: SURGICAL HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH; ignaz-glaser-strasse 53; buermoos, salzburg 5111 ; AU 5111
• MDR Report Key: 8295675
• Report Number: 9681479-2019-00001
• Device Sequence Number: 2701556
• Product Code: KMW
• UDI-Device Identifier: J021300610001
• UDI-Public: J021300610001
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K080939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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?: No
• Operator of Device: No Information
• Device Model Number: S-12
• Device Catalogue Number: 30061000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2019
• Initial Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1