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

Model Number	00711115
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event was returned to steris endoscopy for evaluation.Upon testing, it was found that the handle worked as expected but the snare loop would not fully deploy when the handle was actuated.The user facility properly tested the unit prior to use as stated in the instructions for use.The ifu states, "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." the lot was manufactured in february 2022 and there have been no other complaints associated with this lot.No additional issues have been reported.
Event or Problem Description
The user facility reported via a vigilance report (technical complaint) to anvisa that the handle to their exacto cold snare would not open after being removed from the packaging.There was no patient involvement as this was identified prior to use.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: 17415108
• Report Number: 1528319-2023-00032
• Device Sequence Number: 21088830
• Product Code: FGX
• UDI-Device Identifier: 00724995182618
• UDI-Public: 00724995182618
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/28/2023

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: 00711115
• Device Catalogue Number: 00711115
• Device Lot Number: 2201836
• 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: 07/14/2023
• Initial Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2022
• 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