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

Model Number	00715050
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was returned to us endoscopy for evaluation.Examination of the device found the that the mesh loop assembly was detached at the connection to the drive cable.Examination also noted damage to the distal catheter and snare loop characteristic of excessive bending prior to deployment of the mesh loop, which contributed to the separation of the mesh loop.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.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." us endoscopy has scheduled in-service training with the user facility regarding proper insertion technique to avoid kinking the device.No additional issues have been reported.
Event or Problem Description
The user facility reported that the mesh loop of a roth net platinum retriever detached from the device during a procedure to retrieve gastric polyps.The procedure was completed using a second roth net device, and the detached portion was retrieved.There was no report of 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: 8808260
• Report Number: 1528319-2019-00027
• Device Sequence Number: 16748545
• Product Code: FDI
• UDI-Device Identifier: 00816765011973
• UDI-Public: (01)00816765011973
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K182909
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: 03/18/2022
• Device Model Number: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: 1903302
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1