MAUDE Adverse Event Report: US ENDOSCOPY COINTIP

Model Number	00711110
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported during a patient procedure that three of their cointip snares were not operating properly and the third snare caught on the wire around the polyp.User facility personnel utilized biopsy forceps to remove the polyp and release the snare resulting in a procedure delay.No report of injury.
Additional Manufacturer Narrative
Steris endoscopy has requested the return of the devices of the reported event for further evaluation.The instructions for use states: "the following conditions may not allow the cointip¿ snare to function properly: advancing the handle to the open position with too much speed or force, attempting to insert or actuate the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or, actuating the device while the handle is at an acute angle in relation to the sheath.Do not use this product if the device does not function properly or there is evidence of damage (e.G.Bent, split, or kinked catheter, snare irregularities, or damaged packaging).Save the device and packaging and contact your local steris endoscopy product specialist.Note: the markings on the handle are for reference only.To reference the point where the snare loop is fully closed; open the snare fully, then slowly close the snare handle until the snare tip meets the end of the outer catheter.Observe the marking on the snare handle where the snare tip meets the end of the snare outer catheter.This will minimize the possibility of cold snaring the polyp." a complaint review confirmed this to be an isolated event for the subject lot.A follow-up mdr will be submitted should additional information become available.
Additional Manufacturer Narrative
The devices subject of the reported event were returned for evaluation and found two of the used devices were significantly damaged and untestable due to kinks, disassembly, and cable protrusion.The third used device had a buckle but remained functional.All unused devices functioned as intended.The cause of the reported event is likely attributed to excessive force during retraction.Steris offered in-service on the proper use and operation of the cointip snare however, the user facility declined.No additional issues have been reported.

• Brand Name: COINTIP
• Common Device Name: COINTIP
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4404130648
• MDR Report Key: 21596820
• Report Number: 1528319-2025-00018
• Device Sequence Number: 15688167
• Product Code: FDI
• UDI-Device Identifier: 00724995194369
• UDI-Public: (01)00724995194369(17)270216(11)240216(10)8569030
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 03/13/2025

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 Model Number: 00711110
• Device Catalogue Number: 00711110
• Device Lot Number: (10)8569030
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2024
• 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