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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The user facility reported that the handle of the device became damaged during the procedure.User facility personnel cut the handle of the device in order to withdraw the endoscope, then successfully withdrew the device separately from the endoscope.The bolus was retrieved and the procedure was completed with no harm to the patient.Damage to the device handle is characteristic of the application of excessive force by the user.The lot number of the subject device is not known.Statements in the instructions for use include: "avoid blindly passing the roth net device past any foreign object, particularly if the entire lumen is blocked.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/or actuating the device when the handle is at an acute angle in relation to the sheath." us endoscopy has offered in-service training on the use of roth net retrievers to the user facility, and the facility has accepted.
Event or Problem Description
The user facility reported difficulty removing a roth net device with captured material during a food bolus removal procedure, resulting in a procedural delay.The procedure was completed with no reported harm to the user or patient.

• 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: 8971502
• Report Number: 1528319-2019-00034
• Device Sequence Number: 3295368
• Product Code: FDI
• UDI-Device Identifier: 00816765010860
• UDI-Public: (01)00816765010860
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/06/2019

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 Model Number: 00711050
• Device Catalogue Number: 00711050
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1