MAUDE Adverse Event Report: US ENDOSCOPY ROTH NET; ROTH NET POLYP RETRIEVAL

Model Number	00711150
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event is not available for evaluation.Without the return or inspection of the device, an exact cause cannot be determined.The instructions for use for the roth net polyp retrieval states, "do not use if the device is damaged or if the packaging has been compromised.Save the device and packaging and contact your local steris endoscopy product specialist.Short strokes, 1"-1.5" (2.5cm - 3.8cm) in length, are recommended throughout device passage to avoid sheath kinking.The following conditions may not allow the roth net 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." the device history record was reviewed for the subject lot and no abnormalities were noted.A complaint review was performed and confirmed the event to be isolated for the subject lot.Steris offered in-service training on the proper use and operation of the roth net polyp retrieval; however, the user facility has declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that the net to their roth net polyp retrieval detached from the device and had to be removed from the patient.User facility personnel had to utilize another device to finish the procedure resulting in a short delay.The procedure was completed successfully, no report of injury.

• Brand Name: ROTH NET
• Common Device Name: ROTH NET POLYP RETRIEVAL
• 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: 22109374
• Report Number: 1528319-2025-00044
• Device Sequence Number: 7023014
• Product Code: FDI
• UDI-Device Identifier: 00724995182670
• UDI-Public: (01)00724995182670(11)241204(17)271204(10)11598892
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 05/29/2025

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: 00711150
• Device Catalogue Number: 00711150
• Device Lot Number: (10)11598892
• 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: 04/29/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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