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

Model Number 00711774

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2019

Event Type  malfunction  

Manufacturer Narrative

Through follow-up with the user facility, us endoscopy has learned that the tip of the scope was not dried prior to cap attachment and medical tape was not used to secure the cap, contrary to the instructions for use.The instructions for use include the following statements: "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." 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 devices subject of the reported events were not retained by the user facility for evaluation.Us endoscopy performed dimensional inspection on devices from the same lot, which confirmed the devices were within specification.Us endoscopy provided the facility with in-service training including instruction on attaching and securing the cap to the endoscope.No additional issues have been reported.

Event Description

The user facility reported the reveal distal attachment caps separated from the endoscope during colonoscopy procedures, requiring intervention to retrieve caps.User facility personnel reported a procedure delay as they had to retrieve the caps.There was no reported harm to patient.

• 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: 8944722
• MDR Text Key: 156588639
• Report Number: 1528319-2019-00033
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 00816765012697
• UDI-Public: (01)00816765012697
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/27/2022
• Device Model Number: 00711774
• Device Catalogue Number: 00711774
• Device Lot Number: 1908499
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• 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