MAUDE Adverse Event Report: Cantel Medical (Italy) S.r.l. ENDODRY; ENDODRY one-click Storage and Drying System

Model Number	Storage and Drying Cabinet
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that they are observing damage to their scopes after being stored in their endodry storage and drying system.One of these scopes was later used in a patient procedure, and a colonic hematoma was reported.
Additional Manufacturer Narrative
Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.

• Brand Name: ENDODRY
• Common Device Name: ENDODRY one-click Storage and Drying System
• Manufacturer (Section D): Cantel Medical (Italy) S.r.l.; via laurentina, 169; pomezia roma 71 ; IT 71
• Manufacturer (Section G): Cantel Medical (Italy) S.r.l.; via laurentina, 169; pomezia roma 71 ; IT 71
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50251933
• Report Number: 3012708860-2026-00002
• Device Sequence Number: 13307688
• Product Code: PUP
• UDI-Device Identifier: 18011517151207
• UDI-Public: (01)18011517151207
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 08/14/2026

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: Storage and Drying Cabinet
• Device Catalogue Number: 15120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2026
• Initial Report FDA Received Date: 08/14/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown