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

Model Number	SURGICAL HANDPIECE
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a dental surgica treatment the instrument got hot and it ended up in burning the patient's lip (2nd degree).The injury is reversible and the patient is under monitoring.After evaluation of the suspect device it came out that the adverse event occured due to wrong lubrication of the instrument.

• 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: 8517118
• Report Number: 9681479-2019-00002
• Device Sequence Number: 1629226
• 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): 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: No Information
• Device Model Number: SURGICAL HANDPIECE
• Device Catalogue Number: 30061000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization