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

Model Number 00711773

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/29/2021

Event Type  malfunction  

Event 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.

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
• Type of Device: DISTAL ATTACHMENT CAP
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 11386915
• MDR Text Key: 246710535
• Report Number: 1528319-2021-00006
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 00724995184766
• UDI-Public: (01)00724995184766
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1