MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ROTH NET RETRIEVER - SELECT; RETRIEVAL DEVICE

Model Number	00711170
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following receipt of this medwatch steris endoscopy complaint records were reviewed, and no matching event was found based on the given part number, lot number, and date of event; therefore, the user facility is unknown.The device subject of this complaint was not returned to steris endoscopy for evaluation.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Statements in the instructions for use include: " the following conditions may cause the device to function improperly: 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.Actuating the device in an extremely coiled position.Actuating the device when the handle is at an acute angle in relation to the sheath.".
Event or Problem Description
Steris endoscopy received an anonymous medwatch report (mw5097835) which reported that a roth net would not fully close during a procedure.The report stated that there was no harm to the patient.

• Brand Name: ROTH NET RETRIEVER - SELECT
• Common Device Name: RETRIEVAL DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 11133819
• Report Number: 1528319-2021-00002
• Device Sequence Number: 16892637
• Product Code: FDI
• UDI-Device Identifier: 00816765013519
• UDI-Public: (01)00816765013519
• Combination Product (Y/N): N
• PMA/510(K) Number: K182909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/07/2021

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 Expiration Date: 09/12/2022
• Device Model Number: 00711170
• Device Catalogue Number: 00711170
• Device Lot Number: 1912761
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1