MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 875101

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Type  Injury  

Event Description

It was reported that a midwest e mini overheated and burn a patient's cheek.The doctor administered iv meds for the burn.

Manufacturer Narrative

Therefore, because a serious injury resulted, this event is reportable per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Manufacturer Narrative

Handpiece failed specs due to cap sticking inwards position coming intact with rotor.Cap grime built up on outside of cap.Visible black mark on outside of cap.No issue found with turbine bearings, replaced head drive.Replaced water hoses and water valve.

• Brand Name: MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
• Type of Device: HANDPIECE, AIR-POWERED, DENTAL
• Manufacturer (Section D): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer (Section G): SIRONA DENTAL SYSTEMS GMBH; fabrikstrasse 31; bensheim, hessen D-646 25; GM D-64625
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 14436389
• MDR Text Key: 292036001
• Report Number: 9614977-2022-00033
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 875101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 05/11/2022
• Supplement Dates FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1