MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. EXACTO COLD SNARE

Model Number	711115
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exacto cold snares subject of the reported event were returned for evaluation.Evaluation results determined that when actuating the exacto cold snare, the l-bend in the hypo tube used to connect the snare/loop was not fully bent.The insufficient bend in the hypo tube could have allowed the hypo tube to slip out of the snap cap when the device was being used.Steris endoscopy's production management team was made aware of the reported event.A review of exacto cold snare complaints was performed and confirmed this is the only complaint received for the subject lot.The instructions for use states that the following conditions may not allow the device to perform properly: "prior to clinical use, inspect and familiarize yourself with the device.If there is evidence of damage, do not use this product and contact your local product specialist.Attempting to advance 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, attempting to actuate the device when the handle is at an acute angle in relation to the sheath." steris offered in-service on the proper use and operation of the exacto cold snare however, the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch report (b)(4), that during patient procedures their exacto cold snares remained opened and were not operating properly.User facility personnel utilized another device, and the patient procedure was completed successfully.No report of injury.

• Brand Name: EXACTO COLD SNARE
• Common Device Name: 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: 16557699
• Report Number: 1528319-2023-00005
• Device Sequence Number: 16886591
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: 00724995182618
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2023

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 Model Number: 711115
• Device Catalogue Number: 711115
• Device Lot Number: 4718301
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 03/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown