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

Model Number 00711559

Device Problems Fluid/Blood Leak (1250); Device Damaged by Another Device (2915)

Patient Problem Insufficient Information (4580)

Event Date 10/16/2020

Event Type  malfunction  

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 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
• Type of Device: IRRIGATION KIT
• 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: 10864268
• MDR Text Key: 223614933
• Report Number: 1528319-2020-00039
• Device Sequence Number: 1
• Product Code: PRT
• UDI-Device Identifier: 00724995183943
• UDI-Public: (01)00724995183943
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1