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

Model Number 00711770

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

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.A distributor in (b)(6), (b)(4), reported to us endoscopy that during a case the 00711770 reveal distal attachment cap detached from the endoscope.The detached device was recovered resulting in a 15-minute delay in the procedure.There was no harm to the patient or user as a result of the detachment or recovery of the reveal device.Investigation into the report found that the customer was using the wrong size reveal distal attachment cap for the endoscope used in the procedure.The hospital was provided additional training on the selection of the proper size of reveal.The device was not returned to us endoscopy for evaluation.A review of the device history record found no nonconformances during the manufacture of this device and all in-process and final inspections were completed with acceptable results documented.The instructions for use (ifu) included for the reveal distal attachment cap include a compatibility chart for selecting the proper sized device.The ifu also contains the following warning and precautions: 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 the 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.Secure the reveal distal attachment cap to the endoscope using medical grade tape ensuring not to cover the side hole.Device not returned to manufacturer.

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.A distributor in (b)(6), (b)(4), reported to us endoscopy that during a case the 00711770 reveal distal attachment cap detached from the endoscope.The detached device was recovered resulting in a 15-minute delay in the procedure.There was no harm to the patient or user as a result of the detachment or recovery of the reveal device.

• Brand Name: REVEAL DISTAL ATTACHMENT CAP
• Type of Device: DISTAL 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: 5564268
• MDR Text Key: 42954470
• Report Number: 1528319-2016-00011
• Device Sequence Number: 1
• Product Code: OCX
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K140315
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: 00711770
• Device Catalogue Number: 00711770
• Device Lot Number: 1503793
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2016
• 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
• Patient Outcome(s): Required Intervention