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

Model Number MAXIMA ELITE 2 1:5

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 06/26/2023

Event Type  Injury  

Event Description

After several uses, the product heated up and burned three (3) patients.

Manufacturer Narrative

Related report number: (b)(4).The complained contra-angle handpiece was examined by w&h and no technical fault on the part of w&h could be detected.Thus, the initial assessment (lack of maintenance) of the distributor as the cause of the strong heating can be confirmed as plausible.

• Brand Name: MAXIMA ELITE
• Type of Device: 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: 17600814
• MDR Text Key: 321711849
• Report Number: 3011300255-2023-00005
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00304040153857
• UDI-Public: 0100304040153857
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/22/2023

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
• Device Operator: Health Professional
• Device Model Number: MAXIMA ELITE 2 1:5
• Device Catalogue Number: 30431000
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/28/2023
• Initial Date FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2022
• 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
• Patient Sex: Male