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	08/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was not returned for investigation.Without the return of the device, the exact cause of the reported event cannot be determined.The roth net ifu states, "the following conditions may not allow the roth net device to function properly: advancing the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or actuating the device when the handle is at an acute angle in relation to the sheath.Short strokes, 1"-1.5" (2.5cm - 3.8cm) in length, are recommended throughout device passage to avoid sheath kinking.The roth net platinum series is designed using a flat wire.Closing or retracting the handle too tightly may cause damage to the device's flat wire.Do not exert excessive "bending" pressure on the open (deployed) device; doing so may disfigure either the flat wire and/or the wire frame's shape." in-service training is pending on the proper use and operation of the roth net platinum.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure, the net to their roth net platinum detached inside a patient.The net was retrieved, and the procedure was completed successfully using a different roth net.No report of injury or delay.
Additional Manufacturer Narrative
Steris offered the user facility in-service training on the proper use and operation of the roth net platinum; however, the user facility declined.Per discussion with user facility personnel, steris learned that contrary to the initial report, the net subject of the reported event did not detach and did not have to be retrieved from a patient.The device history record was reviewed, and there were no abnormalities associated with this lot of products.No additional issues have been reported.

• Brand Name: ROTH NET PLATINUM
• Common Device Name: ROTH NET
• 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 ; 4405197842
• MDR Report Key: 22864179
• Report Number: 1528319-2025-00087
• Device Sequence Number: 7733025
• Product Code: FDI
• UDI-Device Identifier: 00724995182908
• UDI-Public: (01)00724995182908(11)241211(17)271211(10)11600811
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/21/2025

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: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: (10)11600811
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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