MAUDE Adverse Event Report: SIRONA DENTAL SYSTEMS GMBH MIDWEST PHOENIX; HANDPIECE, AIR-POWERED, DENTAL

Catalog Number 791430

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

1 of 1 devices was returned for evaluation.Evaluation of one device found excessive wear due to a lack of proper maintenance.This device had a deformation issue (dent).A friction problem was identified from pressure on the cap.The device did not heat up during evaluation.The device was repaired and returned to the customer.This event is being submitted as part of vmsr.Only one event was received for this device during this quarter.

Event Description

This report summarizes 1 malfunction event where a midwest phoenix handpiece overheated.No injury resulted.

• Brand Name: MIDWEST PHOENIX
• 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.; york, PA 17401 ; 7178494593
• MDR Report Key: 17390882
• MDR Text Key: 319706670
• Report Number: 9614977-2023-00031
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• PMA/PMN Number: K131319
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 791430
• Patient Sequence Number: 1