MAUDE Adverse Event Report: STERIS CORPORATION VERIFY; VERIFY STEAM INTEGRATING INDICATOR

Model Number	STEAM INTEGRATING
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The devices subject to the reported event have been discarded.Without the returned devices, a cause of the reported event cannot be determined.The dhr for the subject lot was reviewed and confirmed the lot was manufactured according to specifications; no abnormalities were noted.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch #(b)(4) that multiple verify steam integrating indicators failed to turn due to not having the solution in the indicator for it to change properly.No report of injury.

• Brand Name: VERIFY
• Common Device Name: VERIFY STEAM INTEGRATING INDICATOR
• Manufacturer (Section D): STERIS CORPORATION; 11457 melrose ave; franklin park IL 60131
• Manufacturer (Section G): STERIS CORPORATION; 11457 melrose ave; franklin park IL 60131
• Manufacturer Contact: daniel davy ; 5960 heisley rd.; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24338230
• Report Number: 3007412809-2026-00001
• Device Sequence Number: 13209261
• Product Code: JOJ
• UDI-Device Identifier: 10724995002104
• UDI-Public: (01)10724995002104(17)300201(10)225C
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2026

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
• Operator of Device: Health Professional
• Device Model Number: STEAM INTEGRATING
• Device Catalogue Number: PCC065
• Device Lot Number: (10)225C
• 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: 01/16/2026
• Initial Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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