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

Model Number	00715050
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of this event was destroyed and is not available for evaluation.The user facility provided pictures of the detached loop; however, without a returned device, the cause of the reported event could not be determined.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: "continuous gentle traction should be applied on the handle to keep the roth net device closed.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, attempting to actuate the device in an extremely coiled position, and actuating the device when the handle is at an acute angle in relation to the catheter." 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
The distributor reported that the distal loop of a roth net platinum retriever became detached during procedural use to retrieve a polyp in the cecum.The detached portion of the device was retrieved, and the procedure was completed using another device with no reported injury to the patient or user.

• Brand Name: ROTH NET PLATINUM RETRIEVER - UNIVERSAL
• Common Device Name: RETRIEVAL DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• MDR Report Key: 10317312
• Report Number: 1528319-2020-00023
• Device Sequence Number: 3484955
• Product Code: FDI
• UDI-Device Identifier: 00816765011973
• UDI-Public: (01)00816765011973
• 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): 07/23/2020

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: No Information
• Device Expiration Date: 05/27/2022
• Device Model Number: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: 1908022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1