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

Model Number	00711170
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility report, the event resulted in a procedure delay.The device subject of this event has not been returned to steris endoscopy for evaluation and therefore the root cause of the reported event cannot be determined at this time.The device history record (lot 1812517, manufactured august 2018, 250 units) was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "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.Confirm that the device continues to open and close smoothly prior to reinsertion into the patient (if removing additional objects is required)." steris endoscopy has requested that the distributor offer in-service training to the user facility.No further issues have been reported.
Event or Problem Description
A user facility reported through the distributor in (b)(6) that, after several passes in a foreign body retrieval procedure, a roth net device became difficult to close.No harm to the patient or user was reported.

• 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: 9739718
• Report Number: 1528319-2020-00006
• Device Sequence Number: 740187
• Product Code: FDI
• UDI-Device Identifier: 00816765013519
• UDI-Public: (01)00816765013519
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K182909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2020

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: 07/31/2021
• Device Model Number: 00711170
• Device Catalogue Number: 00711170
• Device Lot Number: 1812517
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1