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

Model Number	00715050
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to us endoscopy for evaluation.Examination of the device confirmed separation of the distal catheter portion, and found damage to the catheter and drive cable assembly which was not noted in the initial report.Examination of the device has been inconclusive regarding the cause of the catheter separation and source of the additional catheter damage.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.A 3-year complaint review found no other instances of catheter detachment.The instructions for use include the following statements: "do not use this device if there is any apparent shipping or handling damage.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: 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." us endoscopy has requested the distributor offer in-service to the user facility including handling prior to use and the user facility has accepted.Date of training is to be determined.No additional issues have been reported.
Event or Problem Description
The distributor reported that, during the retrieval of a polyp, a portion of the catheter of a roth net detached on first deployment of the device within the patient.Retrieval of the polyp was completed with a second roth net device and the detached portion of the catheter was retrieved.There was no reported harm to the patient.

• Brand Name: ROTH NET PLATINUM - UNIVERSAL
• Common Device Name: RETRIEVAL DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8592811
• Report Number: 1528319-2019-00020
• Device Sequence Number: 19381358
• Product Code: FDI
• UDI-Device Identifier: 00816765011973
• UDI-Public: (01)00816765011973
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/08/2019

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 Expiration Date: 08/10/2020
• Device Model Number: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: 1713142
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1