MAUDE Adverse Event Report: US ENDOSCOPY ROTH NET

Model Number	00711050
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility personnel stated that the plastic surrounding the wire near the handle "crumpled up" and would not allow the wire to move back into the handpiece.Steris has requested the roth net device subject of the reported event be returned for evaluation.The device history record was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed this to be an isolated event for the subject lot.Investigation of the event is currently in progress.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via vigilance report # (b)(4) that following the removal of a coin during a gastroscopy, the net to their roth net device would not close.No report of injury.

• Brand Name: ROTH NET
• Common Device Name: ROTH NET
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 24333626
• Report Number: 1528319-2026-00012
• Device Sequence Number: 9773510
• Product Code: FDI
• UDI-Device Identifier: 00724995182496
• UDI-Public: (01)00724995182496(11)250716(17)280716(10)12570055
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2026

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: 00711050
• Device Catalogue Number: 00711050
• Device Lot Number: (10)12570055
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 02/13/2026
• Date Device Manufactured: 07/16/2025
• 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