MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ROTH NET

Model Number	00711197
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of this complaint was not returned to steris endoscopy for evaluation.The customer provided information and pictures regarding the complaint.It was observed that the hypo tube in the handle assembly had bent which indicates that the user advanced the handle to the open position with too much speed or force, attempted to pass or open the device in an extremely articulated endoscope, attempted to actuate the device in an extremely coiled position and actuated the device when the handle is at an acute angle in relation to the sheath.Additionally, it was observed that there was a buckled catheter below the handle assembly which was attributed to excess force from the user.The instructions for use for the roth net 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 (dhr) was reviewed for the subject lot and no abnormalities were noted.A complaint review was performed and determined the event to be isolated.Steris offered in-service training on the proper use and operation of the roth net device and is awaiting a response.No additional issues have been reported.
Event or Problem Description
The user facility reported that the spring to their roth net popped out of the handle.No report of injury.
Additional Manufacturer Narrative
Steris offered in-service training on the proper use and operation of the roth net, however, the user facility declined.No additional issues have been reported.

• Brand Name: ROTH NET
• Common Device Name: ROTH NET
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 19042459
• Report Number: 1528319-2024-00027
• Device Sequence Number: 15594866
• Product Code: GCJ
• UDI-Device Identifier: 00724995182854
• UDI-Public: 00724995182854
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/04/2024

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: 00711197
• Device Catalogue Number: 00711197
• 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: 03/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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