MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. CO2EFFICIENT ENDOSCOPIC INSUFFLATOR

Model Number 710302

Device Problem Misconnection (1399)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

The co2efficient endoscopic insufflator is designed to use co2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.The co2efficient device is designed to be connected to the endoscope via the air/water port.During the reported event, one co2efficient device was connected to the endoscope air/water port while the second co2efficient device was simultaneously connected to the endoscope accessory port.The connection of the co2efficient device to the accessory port of the endoscope is off-label use, and contrary to the device set-up instructions which are provided in the instructions for use.The cause of the event is attributed to the connection of the co2efficient device to the accessory port of the endoscope, which is off-label use and contrary to the set-up instructions provided in the instructions for use.Us endoscopy counseled the user facility that the insufflator usage associated with this event is not within the intended use, specifically that the co2efficient device is not labeled for use via the accessory port of an endoscope, and that no testing or validation has been performed to assess the safety or efficacy of using two endoscopic insufflators at the same time in two different endoscope ports.Us endoscopy offered formal in-service training to the user facility; however, the user facility declined.No additional issues have been reported.

Event Description

The user facility reported bleeding of the mucosal lining due to over-insufflation during a transoral incisionless fundoplication (tif) procedure which included the simultaneous use of two co2efficient endoscopic insufflators.One of the insufflators was improperly connected to the endoscope via the accessory port, bypassing the air/water valve of the endoscope which is used to manage insufflation during endoscopic procedures.The user facility reported that the patient did not require treatment as a result of the reported event, and the procedure was completed successfully.

• Brand Name: CO2EFFICIENT ENDOSCOPIC INSUFFLATOR
• Type of Device: ENDOSCOPIC INSUFFLATOR
• 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: 8167112
• MDR Text Key: 130974539
• Report Number: 1528319-2018-00041
• Device Sequence Number: 1
• Product Code: FCX
• UDI-Device Identifier: 00826765013090
• UDI-Public: (01)00826765013090
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053008
• 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: 12/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 710302
• Device Catalogue Number: 710302
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1