MAUDE Adverse Event Report: US ENDOSCOPY ROTH NET PLATINUM

Model Number	00715050
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure, their roth net platinum device got stuck on the patient's tissue.User facility personnel utilized another roth net platinum device resulting in a procedure delay.The patient procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The steris territory manager discussed the reported event with user facility personnel who stated that the first roth net that was utilized did not close during the pre-procedure check.The instructions for use states, "remove the device from the package and uncoil the entire device and drape in a "u" shaped configuration, holding the proximal end of the catheter in one hand and the distal end in the opposite hand.Close (retract) and open (deploy) the handle several times and observe that the device functions properly." steris requested the device subject of the reported event be returned for evaluation.The roth net device had biomaterial on the net, a curve underneath the handle assembly and a "c" shape bend in the hypo tube.The bend in the hypo tube is indicative of the user advancing the handle to the open position with too much speed or force, the user attempting to pass or open the device in an extremely articulated endoscope, or the user trying to actuate the device in an extremely coiled position and/or actuating the device when the handle is at an acute angle in relation to the sheath.The instructions for use states, "the following conditions may not allow the roth net device to function properly: advancing the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, (attempting to actuate the device in an extremely coiled position and/or actuating the device when the handle is at an acute angle in relation to the sheath.Short strokes, 1"-1.5" (2.5cm - 3.8cm) in length, are recommended throughout device passage to avoid sheath kinking.Note: excessive closing force may damage the device's wire or cause the net to rupture or tear.Note: exerting excessive "bending" pressure on the open (deployed) device may disfigure the wire shape.The roth net platinum series is designed using a flat wire.Closing or retracting the handle too tightly may cause damage to the device's flat wire.Do not exert excessive "bending" pressure on the open (deployed) device; doing so may disfigure either the flat wire and/or the wire frame's shape.Remove the device from the package and uncoil the entire device and drape in a "u" shaped configuration, holding the proximal end of the catheter in one hand and the distal end in the opposite hand.Close (retract) and open (deploy) the handle several times and observe that the device functions properly." the steris territory manager offered in-service training on the proper use and operation for the roth net platinum device however, the user facility declined.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 44060
• 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: 20010080
• Report Number: 1528319-2024-00066
• Device Sequence Number: 4362906
• Product Code: GCJ
• UDI-Device Identifier: 00724995182908
• UDI-Public: (01)00724995182908
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 08/16/2024

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: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: (10)9013955
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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