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

Model Number	00711770
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow up with the user facility, us endoscopy has learned that medical tape was not used to secure the cap, which is contrary to the directions provided in the instructions for use.Statements in the instructions for use include: "dry the tip of the endoscope by wiping with a 4x4 gauze, or dry wash cloth.It is important that the reveal distal attachment cap and tip of the endoscope are dry to ensure that the device stays attached to the endoscope.Secure the reveal distal attachment cap to the endoscope using medical grade tape ensuring not to cover the side hole." the device subject of this event was not returned to us endoscopy for evaluation.The user facility returned other devices from the same lot, which were evaluated and found to be within specification.The device history record for the subject lot was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.The user facility has declined us endoscopy's offer of in-service training.
Event or Problem Description
The user facility reported that a reveal distal attachment cap detached from the endoscope during procedural use.The device was retrieved, and there was no reported harm to the patient or user.

• 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: 8336203
• Report Number: 1528319-2019-00010
• Device Sequence Number: 11297246
• Product Code: OCX
• UDI-Device Identifier: 00816765012642
• UDI-Public: (01)00816765012642
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K140315
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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: 09/03/2021
• Device Model Number: 00711770
• Device Catalogue Number: 00711770
• Device Lot Number: 1814922
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/14/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1