MAUDE Adverse Event Report: US ENDOSCOPY ROTH NET; ROTH NET MINI

Model Number	00711057
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation for the reported event is in progress; a follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported via user facility medwatch report #2000330000-2024-8082 that during a patient procedure that their roth net mini would not deploy and that the handle was bent.It is unknown if there was any patient harm at this time.
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without the return or inspection of the device, a root cause cannot be determined.It has been reported that there was no report of injury.The roth net mini instructions for use states, "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 lot was manufactured to specifications; no abnormalities were noted.There have been no other complaints associated with this lot.No additional issues have been reported.

• Brand Name: ROTH NET
• Common Device Name: ROTH NET MINI
• 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: 20457005
• Report Number: 1528319-2024-00086
• Device Sequence Number: 21035425
• Product Code: GCJ
• UDI-Device Identifier: 00724995182526
• UDI-Public: (01)00724995182526(11)240409(17)270409(10)9014169
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 10/15/2024

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: 00711057
• Device Catalogue Number: 00711057
• Device Lot Number: (10)9014169
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/09/2024
• 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