MAUDE Adverse Event Report: DENTSPLY LLC SCHICK33 S2 SENSOR SHIP KIT/3.0 CABLE 6'; UNIT, X-RAY, INTRAORAL

Catalog Number	100008624
Medical Device Problem Code	Poor Quality Image (1408)
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.Field service evaluation- problem description (b)(6) 2026, 10:24:50 , (b)(6).Initial log (b)(6) 2026 9:58:28 am (b)(6).Warranty: yes (date of manufacturer 10/27/2025) dealer on-site: no billable: no billing accepted: na billing approved by: na 90 day expiration date: 05/11/2026.Remote access: yes workstation(s): (b)(4).Troubleshooting description: (b)(6) called in requesting help with sensor connectivity issues and x-rays being duplicated.It was discovered the usb interfaces move rooms since they have 3 interfaces and 6 operatories.The problem follows one interface.This is not the original capa referring to old patient / new patient.What happens is an x-ray is taken in one template square, and that same image is duplicated / reproduced in the next template square.Retake images have been taken when this issue occurs.(1 additional image per patient) patient was involved, and no patient injury occurred.This interface (s/n: (b)(6) duplicates images every x-ray during our testing.It's the only interface having this issue, others on the same computer with the same usb cable plugged into the same usb port works fine.Recommending replacing this interface under warranty.
Event or Problem Description
While the customer was using a part of an intraoral sensor system, schick33 s2 sensor ship kit/3.0 cable 6', they allege experiencing image quality issues when an x-ray image was taken and an additional image was required.No injury was reported from the alleged event.

• Brand Name: SCHICK33 S2 SENSOR SHIP KIT/3.0 CABLE 6'
• Common Device Name: UNIT, X-RAY, INTRAORAL
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY LLC; 1301 smile way; york PA 17404
• Manufacturer Contact: dan eagar ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 24430332
• Report Number: 2424472-2026-00574
• Device Sequence Number: 10297820
• Product Code: EAP
• UDI-Device Identifier: D0031000086240
• UDI-Public: D0031000086240
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K093453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: 100008624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/10/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown