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

Model Number	00711770
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris endoscopy learned that contrary to the instructions for use, the user did not use tape to secure the distal attachment cap to the scope.The device subject of the event was not returned for evaluation.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.The reveal® distal attachment cap instruction for use states: "prior to clinical use, inspect and familiarize yourself with the device.If damage (e.G.Tears, misshapen) is noted, do not use this product and contact your local product specialist.Verify that the outer diameter of the endoscope is compatible with the inner diameter of the reveal® distal attachment cap.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 product specialist offered in-service training on the proper use and operation of the device however, the customer has not yet responded.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure the reveal distal attachment cap detached from their olympus gif-h190 scope.The patient was examined however, the cap was not detected.In postoperative care, the patient expelled the cap.The patient is reported to be doing fine.
Additional Manufacturer Narrative
The product specialist offered in-service training on the proper use and operation of the device however, the user facility declined this offer.No additional 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 road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 13659550
• Report Number: 1528319-2022-00012
• Device Sequence Number: 17435854
• Product Code: OCX
• UDI-Device Identifier: 00724995184735
• UDI-Public: 00724995184735
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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: 2102623
• 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: 02/01/2022
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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