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

Model Number 00711772

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2016

Event Type  No Answer Provided  

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.Us endoscopy received a report from a customer indicating that the reveal distal attachment cap detached from the endoscope during a procedure.The complainant reported that the reveal cap became detached from the endoscope in the patient's mouth while the endoscope was being withdrawn from the patient at the conclusion of the procedure.The reveal cap was retrieved with no harm to the patient or user.The device was discarded by the user.The device history record for this device was reviewed and no manufacturing or quality issues were found.All inspections were completed and acceptable results were documented.During the investigation, us endoscopy learned that the user selected the wrong size of the reveal distal attachment cap for the endoscope used in the procedure.The customer was provided with instruction and literature on the proper use of the device.

Event Description

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.Us endoscopy received a report from a customer indicating that the reveal distal attachment detached from the endoscope during a procedure.The complainant reported that the reveal cap became detached from the endoscope in the patient's mouth while the endoscope was being withdrawn from the patient at the conclusion of the procedure.The reveal cap was retrieved with no harm to the patient or user.

• 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 road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 5476415
• MDR Text Key: 39553971
• Report Number: 1528319-2016-00007
• Device Sequence Number: 1
• Product Code: OCX
• 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: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/31/2018
• Device Model Number: 00711772
• Device Catalogue Number: 00711772
• Device Lot Number: 1505931
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2015
• 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
• Patient Outcome(s): Required Intervention