MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. 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	07/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure two reveal distal attachment caps fell off the endoscope tip into the patient.The caps were retrieved, and the patient procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The devices subject of the event were discarded and are not available for evaluation.Steris requested devices from the same box from the user facility for evaluation.Evaluation results determined no issues were noted with the function or operation with the reveal distal attachment caps.Steris offered in-service training to user facility personnel on the proper use and operation for the reveal distal attachment cap and the user facility accepted.The instruction for use provides the user with the following information: "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.Do not use vaseline (or any lubricant that contains petroleum jelly), cooking oils, silicone spray alcohol, or xylocaine spray to lubricate the instrument.Doing so could cause equipment damage or cause the instrument to fall off the endoscope inside the patient.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." the device review history (dhr) for the subject lot was reviewed, and no abnormalities were found, and no other complaints associated with the subject lot.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
Steris performed in-service training on the proper use and operation for the reveal distal attachment cap.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: 17499847
• Report Number: 1528319-2023-00034
• Device Sequence Number: 15079143
• Product Code: OCX
• UDI-Device Identifier: 00724995184735
• UDI-Public: 00724995184735
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/10/2023

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: 5077593
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 07/11/2023; 07/11/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/05/2023; 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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