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

Model Number	00711050
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distributor has requested additional details concerning the incomplete procedure, such as if the procedure has been rescheduled; however, the user facility has not provided any further information.The device subject of this event was returned to steris endoscopy for evaluation.Examination of the returned device found a single separation between the mesh and the wire loop, however the mesh remained attached to the device through additional connection points.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.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.Continuous gentle traction should be applied on the handle to keep the roth net device closed.Excess pressure may cause the net to rupture or tear." the distributor has offered in-service training to the user facility; however, the facility has not responded.No further issues have been reported.
Event or Problem Description
The distributor reported that the mesh component of a roth net device became partially detached during a procedure, and reported the procedure was not completed.There was no report of harm to the patient or user.

• 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: 10495143
• Report Number: 1528319-2020-00029
• Device Sequence Number: 2676260
• Product Code: FDI
• UDI-Device Identifier: 00724995182496
• UDI-Public: (01)00724995182496
• 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): 09/04/2020

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: 11/09/2022
• Device Model Number: 00711050
• Device Catalogue Number: 00711050
• Device Lot Number: 1915313
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1