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

Model Number	00715050
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It should be noted the device is intended to retrieve a food bolus, not intended to push a bolus.The report indicates the device was used in a push bolus procedure, which is not consistent with the intended use for retrieval of a food bolus.Examination of returned product confirmed device damage consistent with the application of excessive force.Statements from the instructions for use include: the disposable roth net retrieval device product line is used in the endoscopic retrieval of foreign body, food bolus and excised tissue such as polyps.Avoid blindly passing the roth net device past any foreign object, particularly if the entire lumen is blocked.The roth net platinum series is designed using a flat wire.Closing or retracting the handle too tightly may cause damage to the device's flat wire.Do not exert excessive "bending" pressure on the open (deployed) device; doing so may disfigure either the flat wire and/or the wire frame's shape.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.In-service training was offered and completed on 1/26/2018.
Event or Problem Description
The user facility reported handle damage and torn retrieval netting during use of multiple roth net devices for an esophageal food bolus procedure.One net became detached from the device and was pushed with the bolus into the stomach.The patient did not require any further treatment due to the net becoming detached.

• 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: 7270924
• Report Number: 1528319-2018-00004
• Device Sequence Number: 16462769
• Product Code: FDI
• UDI-Device Identifier: 00816765011973
• UDI-Public: 00816765011973
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 02/14/2018

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: Physician
• Device Model Number: 00715050
• Device Catalogue Number: 00715050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1