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

Catalog Number 100008633

Device Problem Image Display Error/Artifact (1304)

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

Event Type  malfunction  

Event 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.

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.

• Brand Name: SCHICK33 S2 SENSOR STARTER KIT/3.0 INTERFACE 6FT
• Type of Device: UNIT, X-RAY, INTRAORAL
• 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.; suite 60w; york, PA 17401 ; 7178494593
• MDR Report Key: 17502954
• MDR Text Key: 320883921
• Report Number: 2436911-2023-00011
• Device Sequence Number: 1
• Product Code: EAP
• UDI-Device Identifier: D764100008633
• UDI-Public: D764100008633
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100008633
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1