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U.S. Department of Health and Human Services

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

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SIRONA DENTAL SYSTEMS GMBH MIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT HANDPIECE, AIR-POWERED, DENTAL Back to Search Results
Catalog Number 875101
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Additional serial numbers included in this report: (b)(4). 2 of 18 devices were returned for evaluation. We are awaiting the return of 16 devices. Evaluation of one device found excessive wear due to a lack of proper maintenance. The devices had debris build-up. The device did not heat up during evaluation. The device was repaired and returned to the customer. Evaluation of one device found excessive wear due to a lack of proper maintenance and lubrication. The devices had debris build-up. The device did not heat up during evaluation. The device was repaired and returned to the customer.
 
Event Description
This report summarizes 18 malfunction events where a midwest e mini handpiece overheated. No injury resulted in any of the events.
 
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Brand NameMIDWEST E MINI 1:5 HIGH SPEED CONTRA ANGLE ATTACHMENT
Type of DeviceHANDPIECE, 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 Key12257011
MDR Text Key264494578
Report Number9614977-2021-00032
Device Sequence Number1
Product Code EFB
Combination Product (y/n)N
PMA/PMN Number
K972436
Number of Events Reported18
Summary Report (Y/N)Y
Report Source Manufacturer
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number875101
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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