MAUDE Adverse Event Report: SIRONA DENTAL, INC. SCHICK33 S2 SENSOR STARTER KIT/3.0 INTERFACE 6FT; UNIT, X-RAY, INTRAORAL, PRODUCT CODE: EAP

Catalog Number	100008633
Medical Device Problem Code	Image Display Error/Artifact (1304)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
While no serious injury resulted in this event, if this malfunction recurred, it could cause or contribute to a serious injury or require medical or surgical intervention to preclude such.This event, therefore, is reportable per 21cfr part 803.Usb 3 firmware v1.4 contains an issue in the portion of code used to optimize sensor performance.If the optimization occurs during an exposure or sensor readout, there is a chance that the resulting image will be corrupted.Image data following the point of corruption will consist of data that was previously held in the memory of the usb device.As a result, the presented image may contain a portion of data from a previous exposure.In general, this would be obvious to the user since the presented image would either contain obvious artifacts or different anatomy than expected.
Event or Problem Description
While using a schick 33 sensor intraoral x-ray unit, an incorrect image was displayed during use.This was immediately noticeable to the clinician and no injury resulted.
Additional Manufacturer Narrative
Device that was reported initially for this event is being corrected from schick 33 with ae usb to schick33 s2 sensor starter kit/3.0 interface 6ft.

• Brand Name: SCHICK33 S2 SENSOR STARTER KIT/3.0 INTERFACE 6FT
• Common Device Name: UNIT, X-RAY, INTRAORAL, PRODUCT CODE: EAP
• Manufacturer (Section D): SIRONA DENTAL, INC.; 30-30 47th ave.; suite 500; long island city NY 11101
• Manufacturer (Section G): SIRONA DENTAL, INC.; 30-30 47th ave.; suite 500; long island city NY 11101
• Manufacturer Contact: hannah seevaratnam ; 221 w. philadelphia st.; york, PA 17401 ; 7178494593
• MDR Report Key: 17736321
• Report Number: 2436911-2023-00013
• Device Sequence Number: 14826002
• Product Code: EAP
• UDI-Device Identifier: D764100008633
• UDI-Public: D764100008633
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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 Catalogue Number: 100008633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown