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

Model Number	00711057
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The roth net retriever is intended to be used to retrieve excised polyps, tissue samples, foreign bodies and calculi during flexible and rigid endoscopy procedures.Through follow up with the user facility, us endoscopy learned the event occurred during a procedure to retrieve multiple foreign bodies (coins).The user facility also clarified that the netting on a single roth net device became torn but did not detach from the device, and the procedure was successfully completed with the second roth net device.The device history record was reviewed and confirmed the devices were manufactured to specification.There have been no other complaints associated with this lot.The device subject of this event was not returned to us endoscopy for evaluation.The instructions for use include the following statements: "endoscopically position the roth net - foreign body - mini over the object.For best results, the object should be centered and proximal within 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 - foreign body - mini closed.Excess force may cause the net to rupture or tear.Do not retract the device and the object into the endoscope, this could cause dame to the endoscope and the device.If removing additional objects from the patient is required, conform that the roth net - foreign body - mini opens and closes smoothly prior to reinsertion into the patient." us endoscopy offered in-service training, however the user facility has declined.
Event or Problem Description
Us endoscopy received medwatch # (b)(4) reporting that during an esophagogastroduodenoscopy (egd) for foreign body removal, the physician was attempting to remove the foreign body specimen when the netting broke away from the looping.The event was rectified, however on second attempt the same occurred again.There was no report of patient or user harm.

• Brand Name: ROTH NET - FOREIGN BODY - MINI
• Common Device Name: RETRIEVAL DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8054549
• Report Number: 1528319-2018-00036
• Device Sequence Number: 2125078
• Product Code: FDI
• UDI-Device Identifier: 00816765010891
• UDI-Public: (01)00816765010891
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/08/2018

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: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 00711057
• Device Catalogue Number: 00711057
• Device Lot Number: 1606764
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1