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 10/21/2022

Event Type  malfunction  

Manufacturer Narrative

The device subject of the reported event was returned for evaluation.The needle had disconnected from the internal peek so when it was released the needle stayed deployed.The device history record was reviewed, and no abnormalities were noted.There have been no other complaints associated with this lot.The instructions for use (ifu (b)(4) 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." no additional issues have been reported.

Event Description

The user facility reported that during a procedure while using their lariat snare the needle would not retract.No injury reported.

• 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: 15828077
• MDR Text Key: 307799341
• Report Number: 1528319-2022-00059
• Device Sequence Number: 1
• Product Code: FDI
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00711084
• Device Catalogue Number: 00711084
• Device Lot Number: 2207192
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2022
• 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