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

Model Number 00711772

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/28/2018

Event Type  malfunction  

Manufacturer Narrative

The reveal distal attachment cap has been designed to be attached to the distal end of the endoscope to facilitate endoscopic therapy.The reveal distal attachment cap is intended for the following: gastrointestinal mucosal resection (endoscopic mucosal resection), keeping the suitable depth of endoscope's view field.The user facility reported that a reveal distal attachment cap detached from the endoscope during the endoscope withdrawal through the esophagus.The reveal device was retrieved, the procedure was completed, and there was no reported harm to the patient or user of the device.The lot number of the subject device was unknown, and the device was not returned to us endoscopy for evaluation.The user stated that the patient had a narrow esophagus which required dilation prior to the procedure.The user stated that medical tape was not used to secure the reveal device to the endoscope, 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 ensuring not to cover the side hole.Gently pull on the reveal distal attachment cap to ensure that it is secure." inservice regarding the use of tape with the distal attachment cap was completed on 9/20/2018.

Event Description

The user facility reported that a reveal distal attachment cap detached from the scope in the patient's esophagus during procedural use.The device was retrieved, the procedure was completed, and there was no reported harm to the patient or user of the device.

• 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: 7911400
• MDR Text Key: 122174105
• Report Number: 1528319-2018-00031
• Device Sequence Number: 1
• Product Code: OCX
• UDI-Device Identifier: 00816765012680
• UDI-Public: (01)00816765012680
• 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: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00711772
• Device Catalogue Number: 00711772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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