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	02/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned by the user facility for evaluation.The lot history record was reviewed and confirmed the device was manufactured to specification.The lot was manufactured in october 2017.No other complaints of any type are associated with this lot.Statements from the instructions for use include: do not use this device if there is any apparent shipping or handling damage.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.For best results, the object should be centered and proximal in the net prior to closure.Once entrapment is accomplished, retract the handle until it stops.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.Us endoscopy discussed the event with the user, including the directions for use which are provided in the ifu.
Event or Problem Description
User facility reported that the nylon mesh on a roth net device detached during a food bolus retrieval procedure.The detached mesh was retrieved with a second roth net device.The procedure was completed with the second roth net device.There was no report of harm to the patient or user due to the detached mesh nor the retrieval.

• 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 44060
• MDR Report Key: 7315904
• Report Number: 1528319-2018-00006
• Device Sequence Number: 18858011
• Product Code: FDI
• UDI-Device Identifier: 00816765010860
• UDI-Public: 00816765010860
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: K122462
• 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): 03/06/2018

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: Physician
• Device Expiration Date: 10/07/2020
• Device Model Number: 00711050
• Device Catalogue Number: 00711050
• Device Lot Number: 1716492
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/06/2018
• Patient Sequence Number: 1