MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. REVEAL DISTAL ATTACHMENT CAP

Model Number	00711773
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that a reveal distal attachment cap detached from the scope during procedural use in the right colon.The device was retrieved and there was no reported harm to the patient or user of the device.
Additional Manufacturer Narrative
On follow-up with the user facility, steris endoscopy has learned that medical tape was not used to secure the cap to the scope, contrary to the instructions for use.Statements in the instructions for use include: "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." steris endoscopy has provided in-service training on the use of the reveal distal attachment cap to the user facility, particularly the use of medical tape to secure the device.No further issues have been reported.

• Brand Name: REVEAL DISTAL ATTACHMENT CAP
• Common Device Name: DISTAL ATTACHMENT CAP
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 11386915
• Report Number: 1528319-2021-00006
• Device Sequence Number: 3117354
• Product Code: OCX
• UDI-Device Identifier: 00724995184766
• UDI-Public: (01)00724995184766
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2021

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 Expiration Date: 08/05/2023
• Device Model Number: 00711773
• Device Catalogue Number: 00711773
• Device Lot Number: 2007719
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1