MAUDE Adverse Event Report: W&H DENTALWERK BUERMOOS GMBH, HENRY SCHEIN, MAXIMA ELITE; HANDPIECE

Model Number	MAXIMA ELITE 2 1:5
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	05/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Related report number 3007007357-2024-00018.
Event or Problem Description
The customer described the handpieces are still having overheating issues.
Event or Problem Description
The customer described the handpieces are still having overheating issues.
Additional Manufacturer Narrative
Related report number 3007007357-2024-00018.No investigation could be carried out, because the handpiece was not returned.The device complaint or problem cannot be confirmed.
Additional Manufacturer Narrative
Related report number 3007007357-2024-00018.No investigation could be carried out, because the handpiece was not returned.The device complaint or problem cannot be confirmed.
Event or Problem Description
The customer described the handpieces are still having overheating issues.

• Brand Name: HENRY SCHEIN, MAXIMA ELITE
• Common Device Name: HANDPIECE
• Manufacturer (Section D): W&H DENTALWERK BUERMOOS GMBH,; ignaz-glaser-strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer (Section G): W&H DENTALWERK BUERMOOS GMBH; ignaz glaser strasse 53; buermoos, 5111 ; AU 5111
• Manufacturer Contact: gerhard weidler ; ignaz glaser strasse 53; buermoos, 5111 ; AU 5111
• MDR Report Key: 19759695
• Report Number: 3011300255-2024-00004
• Device Sequence Number: 6623658
• Product Code: EFB
• UDI-Device Identifier: 00304040153857
• UDI-Public: 0100304040153857
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K162926
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MAXIMA ELITE 2 1:5
• Device Catalogue Number: HS: 570-2660 (W&H: 30431000)
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 06/21/2024; 06/21/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/19/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown