MAUDE Adverse Event Report: US ENDOSCOPY SHORT THROW; SHORT THROW SNARE

Model Number	00711018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure as they were attempting to cut out a polyp, their short throw snare would not cut through the tissue when closing the handle creating a procedure delay.
Additional Manufacturer Narrative
Investigation of this event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without the returned device, steris is unable to determine the cause of the reported event.The instructions for use 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.Ensure that the device is compatible with an endoscope channel of 2.8mm or larger before insertion.Remove the device from the package and uncoil the entire device and drape in a "u" shaped configuration, holding the proximal end in one hand and the distal sheath in the opposite hand.Move the finger rings back and forth to confirm that the snare loop opens and closes smoothly prior to inserting into the endoscope.Ensure the snare loop is fully retracted into the catheter prior to insertion into the endoscope.Short strokes, 1"-1.5" (2.5cm - 3.8cm) in length, are recommended throughout device passage to avoid sheath kinking.This device is not designed for use in side viewing endoscopes.The following conditions may not allow a snare device to function properly: (1) advancing the handle to the open position with too much speed or force, (2) attempting to pass or open the device in an extremely articulated endoscope, (3) attempting to actuate the device in an extremely coiled position and/or (4) 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 and operation of the short throw snare; however, the user facility declined.The dhr for the lot subject of the event was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: SHORT THROW
• Common Device Name: SHORT THROW SNARE
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20539743
• Report Number: 1528319-2024-00094
• Device Sequence Number: 12816918
• Product Code: FDI
• UDI-Device Identifier: 00724995182472
• UDI-Public: (01)00724995182472(11)230620(17)260620(10)5806988
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2026
• Device Model Number: 00711018
• Device Catalogue Number: 00711018
• Device Lot Number: (10)5806988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2024
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/20/2023
• 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