MAUDE Adverse Event Report: CARESTREAM DENTAL LLC CS 3600 SINGLE USE NORMAL TIPS

Model Number	CS 3600
Medical Device Problem Codes	Material Separation (1562); Defective Component (2292)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
This is a corrected report.Original mdr number used cfn for carestream health.The original mdr number was: 131703-2021-00001.The corrected mdr number uses the correct fei for carestream dental llc: 3002522649-2021-00001.When using the cs 3600 accessory: cs 3600 single use normal tip, the mirror can be detached from the unit.When this event occurred, the mirror fell from the unit into the patient's mouth.The patient was able to remove the mirror and the patient did not sustain any injuries.The size of the mirror (22mmx13mmx1.5mm) makes it possible for the mirror to be swallowed or aspirated.If the mirror is swallowed or aspirated, surgical intervention would be required to remove the mirror.

• Brand Name: CS 3600 SINGLE USE NORMAL TIPS
• Common Device Name: CS 3600 SINGLE USE NORMAL TIPS
• Manufacturer (Section D): CARESTREAM DENTAL LLC; 3625 cumberland boulevard; suite 700; atlanta GA 30339
• MDR Report Key: 11648699
• Report Number: 3002522649-2021-00001
• Device Sequence Number: 3591773
• Product Code: NOF
• UDI-Device Identifier: 60192156568748
• UDI-Public: 60192156568748
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: NONE
• Number of Events Summarized: 2
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Dentist
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/22/2021

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
• Operator of Device: Health Professional
• Device Model Number: CS 3600
• Device Catalogue Number: 5941216
• Device Lot Number: 2020-06
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1