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	Foreign Body In Patient (2687)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without the return of the device, an evaluation could not be completed, and the cause of the reported event could not be determined.The device history record was reviewed and confirmed the lot subject of the event was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed the reported event to be isolated for the subject lot.Steris performed in-service training on the proper use and operation for the reveal distal attachment cap specifically the importance of properly securing the cap to the endoscope.The instructions for use states, "place the reveal distal attachment cap onto the distal end of the endoscope.Slide the distal end of the endoscope to the alignment line.Secure the reveal distal attachment cap to the endoscope using medical grade tape ensuring not to cover the side hole.Gently pull on the reveal distal attachment cap to ensure that it is secure." no additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch mw5180244 that during a gastrointestinal procedure the end cap of their reveal distal attachment cap "dislodged and was retained in the patient as a foreign object".User facility personnel utilized another device and confirmed the procedure was completed successfully.User facility personnel confirmed the "foreign object" was dislodged and retrieved.

• 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: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 24220902
• Report Number: 1528319-2026-00006
• Device Sequence Number: 8579324
• Product Code: OCX
• UDI-Device Identifier: 00724995184735
• UDI-Public: (01)00724995184735(17)280904(10)12790268
• 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): 01/30/2026

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)12790268
• 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: 01/02/2026
• Initial Report FDA Received Date: 01/30/2026
• 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