MAUDE Adverse Event Report: US ENDOSCOPY REVEAL; DISTAL ATTACHMENT CAP

Model Number	00711770
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2026
Type of Reportable Event	Malfunction

• Brand Name: REVEAL
• Common Device Name: DISTAL ATTACHMENT CAP
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5976 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25855171
• Report Number: 1528319-2026-00085
• Device Sequence Number: 5167516
• Product Code: OCX
• UDI-Device Identifier: 00724995184735
• UDI-Public: (01)00724995184735(11)260223(17)290223(10)13601787
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/17/2026

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: 00711770
• Device Catalogue Number: 00711770
• Device Lot Number: (10)13601787
• 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: 06/18/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2026
• 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