MAUDE Adverse Event Report: STERIS CORPORATION VERIFY RESI-TEST SLIDE-THRU

Model Number	RESI-TEST
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices subject of the reported event were not returned to steris for evaluation.Without the return of the devices, an evaluation could not be completed, and the cause of the reported event could not be determined.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.No additional issues have been reported.
Event or Problem Description
The user facility reported via (b)(4), that "it was discovered while reprocessing an endoscope the resi test brush was shredding when being placed through the scope." no report of injury.

• Brand Name: VERIFY RESI-TEST SLIDE-THRU
• Common Device Name: SLIDE-THRU
• Manufacturer (Section D): STERIS CORPORATION; 9325 pinecone drive; mentor OH 44060
• Manufacturer (Section G): STERIS CORPORATION; 9325 pinecone drive; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25280281
• Report Number: 3004080920-2026-00001
• Device Sequence Number: 13285504
• Product Code: SDC
• UDI-Device Identifier: 00724995231934
• UDI-Public: (01)00724995231934(11)240314(10)29127
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: DEN230085
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RESI-TEST
• Device Catalogue Number: 2D79QH
• Device Lot Number: (10)29127, (10)29765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown