MAUDE Adverse Event Report: US ENDOSCOPY ROTH NET PLATINUM

Model Number	00711155
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The roth net platinum subject of the reported event is unavailable for evaluation; the user facility has not responded to multiple requests for additional information.Without the return or inspection of the subject device, a root cause cannot be determined.The instructions for use (ifu 730988) contains directions that instruct the user the following instructions: "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 and confirmed the subject lot was manufactured to specifications; no abnormalities were noted.A complaint review confirmed this to be an isolated event for the subject lot.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch (b)(4) that during a patient procedure, the net component of the roth net platinum did not open.No report of injury.

• Brand Name: ROTH NET PLATINUM
• Common Device Name: ROTH NET PLATINUM
• 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: 21526213
• Report Number: 1528319-2025-00010
• Device Sequence Number: 9712485
• Product Code: GCJ
• UDI-Device Identifier: 00724995182700
• UDI-Public: (01)00724995182700(11)230204(17)260201(10)5343176
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/05/2025

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 Expiration Date: 02/01/2026
• Device Model Number: 00711155
• Device Catalogue Number: 00711155
• Device Lot Number: (10)5343176
• 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: 02/03/2025
• Initial Report FDA Received Date: 03/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2023
• 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