MAUDE Adverse Event Report: US ENDOSCOPY ROTH NET PLATINUM

Model Number	00715050
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During follow up with user facility personnel regarding the reported event it was stated that the net of the device was stuck on a residual polyp.When the net was pulled out it was observed to be "twisted".As the net of the device was stuck on the polyp the device was unable to release itself.Following the procedure, the roth net device was discarded and is not available for evaluation; therefore, a root cause 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 device and user facility personnel accepted.Steris is working on scheduling a date of the in-service training.No additional issues have been reported.
Event or Problem Description
The user facility reported that during polyp retrieval, the net component of the roth net became stuck on the residual polyp requiring intervention to release the net.The procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
Steris counseled user facility personnel on the proper use and operation for the roth net device.Additionally, formal in-service training is being scheduled for a later date.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 OH
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4404130648
• MDR Report Key: 20915799
• Report Number: 1528319-2024-00106
• Device Sequence Number: 7824892
• Product Code: GCJ
• UDI-Device Identifier: 00724995182908
• UDI-Public: (01)00724995182908(11)240509(17)270509(10)10263784
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 12/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: (10)10263784
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2024
• 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