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	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their roth net platinum detached from the device.The procedure was completed successfully using a grasper.No report of injury or procedure delay.
Additional Manufacturer Narrative
The device subject of the reported event was returned to steris for evaluation.Evaluation results found that the loop cable of the net was damaged, however an exact cause of the reported event could not be determined.The roth net platinum ifu 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.Keep the device closed by applying continuous/steady traction to the handle.Note: excessive closing force may damage the device's wire or cause the net to rupture or tear." a steris account manager offered in-service training on the proper use and operation of the roth net platinum.The user facility accepted this offer and a date is being scheduled to complete the in-service training.This is an isolated event for this lot of products.A follow-up report will be submitted when additional information is available.
Additional Manufacturer Narrative
A steris account manager provided in-service training on the proper use and operation of the roth net platinum.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 ; 4403586251
• MDR Report Key: 22976343
• Report Number: 1528319-2025-00092
• Device Sequence Number: 9177210
• Product Code: GCJ
• UDI-Device Identifier: 00724995182908
• UDI-Public: (01)00724995182908(11)250618(17)280618(10)12496047
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 09/05/2025

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)12496047
• 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: 08/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/18/2025
• 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