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

Catalog Number 875205

Device Problem Overheating of Device (1437)

Patient Problems Burn(s) (1757); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional serial numbers included in this report: (b)(4).53 of 55 devices were returned for evaluation.We are awaiting the return of one device.One device will not be returned for evaluation.Evaluation of 41 devices found excessive wear due to a lack of proper maintenance.The devices had debris build-up.The devices did not heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of 9 devices found excessive wear due to a lack of proper maintenance.The devices had debris build-up.The devices did heat up during evaluation.The devices were repaired and returned to the customers.Evaluation of 3 devices found excessive wear due to a lack of proper maintenance and lubrication.The devices had debris build-up.The devices did not heat up during evaluation.The devices was repaired and returned to the customers.

Event Description

This report summarizes 55 malfunction events where a midwest e plus handpiece overheated.In 2 events, the outcome is unknown.In 12 events, the patient's experienced minor burns that did not require intervention.In 41 events, no injury resulted.

• Brand Name: MIDWEST E PLUS 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: 12725500
• MDR Text Key: 279289588
• Report Number: 9614977-2021-00056
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K972436
• Number of Events Reported: 55
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 875205
• Type of Device Usage: N
• Patient Sequence Number: 1