MAUDE Adverse Event Report: US ENDOSCOPY ROTH NET PLATINUM

Model Number	00715160
Medical Device Problem Codes	Mechanical Problem (1384); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 that during a patient procedure, the net from their roth net platinum got caught on a clip that had been placed at the base of the polyp in the colon.User facility personnel cut the net at the handle outside of the patient to remove the colonoscope from the patient.The polyps were successfully removed and retrieved.It was confirmed during a follow-up appointment that the net was not present in the patient.No report of injury.
Additional Manufacturer Narrative
Steris requested the roth net platinum subject of the reported event be returned for evaluation; however, the device was not available.Without the return or evaluation of the subject device, a cause of the event cannot be determined.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.Steris offered in-service training on the proper use and operation for the roth net platinum; however, the user facility declined.No additional issues have been reported.

• 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 ; 4403586251
• MDR Report Key: 22478781
• Report Number: 1528319-2025-00074
• Device Sequence Number: 8016366
• Product Code: FDI
• UDI-Device Identifier: 00724995182939
• UDI-Public: (01)00724995182939(11)231219(17)261219(10)8013773
• 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): 07/11/2025

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: 00715160
• Device Catalogue Number: 00715160
• Device Lot Number: (10)8013773
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown