MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ISNARE SYSTEM - LARIAT SNARE

Model Number 00711084

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

Two devices were returned to steris from the user facility for evaluation.One device had a detached luer component and both devices were found to be curved/bent, all of which is indicative of excess force and improper handling by user facility personnel.Additionally, the needle for one of the returned devices had separated from the internal catheter which caused the needle to remain deployed.The cause of the separated needle could not be determined.The device history records were reviewed, and no abnormalities were noted.There have been no other complaints associated with these lots.The instructions for use gives the following instruction to the user, "prior to clinical use, inspect and familiarize yourself with the device.If there is evidence of damage (i.E.Deformed or bent snare or needle, inoperable handle, damaged packaging), do not use this product and contact your local product specialist.The following conditions may not allow the isnare system - lariat snare device to function properly: advancing the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or actuating the device when the handle is at an acute angle in relation to the sheath".Steris offered in-service training on the proper use of the isnare system - lariat snare; however, the user facility declined this offer.No additional issues have been reported.

Event Description

The user facility reported that following use of their isnare system - lariat snares during procedures for injections the needle would not retract.No report of injury.

• Brand Name: ISNARE SYSTEM - LARIAT SNARE
• Type of Device: SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 17309890
• MDR Text Key: 319018163
• Report Number: 1528319-2023-00026
• Device Sequence Number: 1
• Product Code: FBK
• UDI-Device Identifier: 00724995180782
• UDI-Public: 00724995180782
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00711084
• Device Catalogue Number: 00711084
• Device Lot Number: 5144729, 5066392
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2023
• Initial Date FDA Received: 07/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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