MAUDE Adverse Event Report: DENTSPLY LLC SCHICK33 S2 SENSOR RMA KIT, 6FT; UNIT, X-RAY, INTRAORAL

Catalog Number	B1218051
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- solution description (b)(6) 2026 , 17:51:25 , (b)(6).It was determined that the schick 33 s2 2.0 sensor will need to get replaced.Part # b1218051 oow part.Customer note (b)(6) 2026, 09:37:21, (b)(6).Did the reported issue require multiple images / multiple exposures to be taken on a patient: yes were there any injuries or mis diagnosis if multiple images/exposures were needed: no ds ticket # or troubleshooting: issue reported: auto-firing - randomly adding white images between exposures.Did the reported issue require multiple images / multiple exposures to be taken on a patient yes/no - do not put na): yes.Were there any injuries or misdiagnosis if multiple images/exposures were needed: no equipment typ e and model: 33 2.0.Serial number: (b)(6) kit js20007769 exp 12/6/24.Confirm sensor cable color: blue.Acquisition soft ware & version: es 24.2.Issue in one or all rooms: all other sensors work with working remotes in room(s) with issue: yes schick driver version (programs and features): ioss remote fw/fpga version: 2.38/1.15 sensor fw version: 3.4 if remote issue: 2.0 or 3.0 : tried different usb cable/usb port/bypassed usb hubs/extenders: yes 3.0 remote: tried on a 3.0 and 2.0 usb port/cable clip connected: yes if sensor issue, replaced elastomer: yes if sensor issue, tried different sensor cable: yes - worked for a short time and is giving auto-firing again.If no response to radiation, confirmed xray head functional: na additional troubleshooting steps/note s: na.
Event or Problem Description
While the customer was using a part of an intraoral sensor system, schick33 s2 sensor rma kit, 6ft, they allege the device self triggered, causing an x-ray image to be taken without prompting the device to take an image.No injury was reported from the alleged event.

• Brand Name: SCHICK33 S2 SENSOR RMA KIT, 6FT
• 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: 24506658
• Report Number: 2424472-2026-00592
• Device Sequence Number: 10456374
• Product Code: EAP
• UDI-Device Identifier: D003B12180510
• UDI-Public: D003B12180510
• Combination Product (Y/N): N
• PMA/510(K) Number: K093453
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2026

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: B1218051
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/09/2026
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown