MAUDE Adverse Event Report: STERIS ITALY S.R.L. CLEANASCOPE; STERILE COVER

Model Number	STERILE TRAY LINER SYSTEM
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into the reported event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via vigilance report that the sterile transparent endoscope cover to their cleanascope "tears as soon as tension is applied to it on the tray".No report of injury.

• Brand Name: CLEANASCOPE
• Common Device Name: STERILE COVER
• Manufacturer (Section D): STERIS ITALY S.R.L.; via laurentina, 169; pomezia, 00071 ; IT 00071
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25524330
• Report Number: 3012708860-2026-00001
• Device Sequence Number: 5547380
• Product Code: FFY
• UDI-Device Identifier: 18011517135801
• UDI-Public: (01)18011517135801(11)250803(10)2508037602
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 06/16/2026

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: STERILE TRAY LINER SYSTEM
• Device Catalogue Number: 103580
• Device Lot Number: (10)2508037602
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 06/16/2026
• Date Device Manufactured: 08/03/2025
• 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