MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. IRRIGATION KIT - CO2 LONG

Model Number	00711559
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow up with the user facility, the leak reportedly occurred on the water tubing adjacent to a pinch clamp.The pinch clamp was reported to have been moved along the tubing while in a closed position.Such movement would place abnormal stress on the tubing and could cause the reported event to occur.Statements from the instructions for use include: "prior to clinical use, inspect and familiarize yourself with the device and review the diagram below.If there is evidence of damage, do not use this product and contact your local product specialist.Both pinch clamps should be in the open position when removed from the package." the device subject of this complaint was not retained for evaluation.However, the user facility returned another device from the same lot for evaluation.Testing of the returned unit was unable to duplicate the reported event.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.Steris endoscopy provided in-service training to the user facility on the proper use and setup of the irrigation kit.No further issues have been reported.
Event or Problem Description
The user facility reported that water was leaking from their irrigation kit tubing damaging the video processor.This resulted in a procedure delay.There was no reported harm to the patient or users.

• Brand Name: IRRIGATION KIT - CO2 LONG
• Common Device Name: IRRIGATION KIT
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 10864268
• Report Number: 1528319-2020-00039
• Device Sequence Number: 11430715
• Product Code: PRT
• UDI-Device Identifier: 00724995183943
• UDI-Public: (01)00724995183943
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/10/2021
• Device Model Number: 00711559
• Device Catalogue Number: 00711559
• Device Lot Number: 2006647
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1