MAUDE Adverse Event Report: US ENDOSCOPY ROTH NET PLATINUM

Model Number	00715050
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the event was returned to steris for evaluation.The evaluation found that the net had detached from the rest of the device.The exact cause of the reported event could not be determined.A complaint review for the lot subject of the reported event confirmed this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that during use of the net to their roth net platinum broke off.The net was removed with another device, and then procedure was completed successfully.No report of injury.

• Brand Name: ROTH NET PLATINUM
• Common Device Name: ROTH NET PLATINUM
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5976 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 24888627
• Report Number: 1528319-2026-00031
• Device Sequence Number: 10419949
• Product Code: FDI
• UDI-Device Identifier: 00724995182908
• UDI-Public: (01)00724995182908(11)240409(17)270409(10)9142012
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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): 04/15/2026

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: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: (10)9142012
• 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: 03/16/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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