MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ROTH NET - FOREIGN BODY - STANDARD; RETRIEVAL DEVICE

Model Number	00711050
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of this event was discarded by the user facility and therefore is not available for evaluation by steris endoscopy.The device history record 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: "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 distributor has offered in-service training to the user facility; however, the facility has declined.No further issues have been reported.
Event or Problem Description
A user facility reported through the distributor in (b)(6) that a roth net device did not fully open nor fully close during a procedure.The roth net was replaced with a second roth net device and the procedure was completed.No harm to the patient or user was reported.

• Brand Name: ROTH NET - FOREIGN BODY - STANDARD
• Common Device Name: RETRIEVAL DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• MDR Report Key: 9922973
• Report Number: 1528319-2020-00011
• Device Sequence Number: 11322372
• Product Code: FDI
• UDI-Device Identifier: 00816765010860
• UDI-Public: (01)00816765010860
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 04/02/2020

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: 05/22/2022
• Device Model Number: 00711050
• Device Catalogue Number: 00711050
• Device Lot Number: 1908391
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1