MalfunctionEHD

SCHICK 3.0 USB INTERFACE

Received Aug 10, 2023

Report 2436911-2023-00008 · MDR key 17503043

Device

Generic name

Unit, X-ray, Extraoral With Timer

Manufacturer

Sirona Dental, Inc.

Model number

Catalog number

100008286

Lot number

Product problems

Image Display Error/Artifact
Image Display Error/Artifact

Patient

Unknown

No Clinical Signs, Symptoms or Conditions
No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

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

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.