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

Model Number 00711084

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2020

Event Type  malfunction  

Manufacturer Narrative

The isnare system - lariat snare is intended for use with or without diathermic energy.Use without diathermic energy is recommended for the resection of diminutive polyps (less than 6 mm).The procedure was reported to be a resection of a 10mm sessile polyp without the use of diathermic energy.A portion of the device subject of the reported event was returned to us endoscopy for evaluation, which confirmed the loop had detached near the connection to the control cable.The connection could not be fully evaluated as the loop component was not returned.The lot number of the subject device is unknown.Statements in the instructions for use include: "snaring without use of monopolar diathermic energy is recommended for the resection of diminutive polyp tissue.To avoid patient injury, do not apply excessive force to the snare while resecting tissue.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." a us endoscopy representative has offered in-service training regarding use of the isnare system - lariat system to the facility; however, the facility has not yet responded.No additional issues have been reported.

Event Description

The user facility reported detachment of the snare loop during resection of a sessile polyp.The snare loop was immediately retrieved.The resection was completed with a second isnare system - lariat snare device and a hemoclip was placed over the tissue at the resection site.

• Brand Name: ISNARE SYSTEM - LARIAT SNARE
• Type of Device: ISNARE
• 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: 9829975
• MDR Text Key: 204572925
• Report Number: 1528319-2020-00007
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152035
• 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: 03/13/2020

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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