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

Model Number	00711155
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One of the two devices subject of the reported event was returned to us endoscopy in a damaged state along with three unused devices from the same box.The second device subject of the reported event was not retained for return by the user facility.Examination of the device subject of the event revealed damage to the device catheter indicative of excessive force having been applied during device actuation.There was no evidence of damage to the distal wire loop or net of the device.The device subject of the event was returned with the distal end cut off, and therefore functional testing could not be conducted.The unused devices returned with the subject device were tested and found to be fully functional.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.Statements in the device ifu include: "keep gentle traction on the device during retrieval.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." us endoscopy has offered in-service training on the use of the device; however, the user facility has declined.
Event or Problem Description
The user facility reported that during retrieval of a food bolus in the esophagus, the user could not retract the roth net device, requiring device withdrawal with the net loop deployed.The procedure continued with a second roth net device, which also could not be retracted.The food bolus procedure was then completed with a third retrieval device.Esophageal scraping was reported; however, no treatment was required as a result.The procedure was completed successfully.

• Brand Name: ROTH NET PLATINUM - FOOD BOLUS
• Common Device Name: RETRIEVAL DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8438204
• Report Number: 1528319-2019-00014
• Device Sequence Number: 1633564
• Product Code: FDI
• UDI-Device Identifier: 00816765011270
• UDI-Public: (01)00816765011270
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 03/20/2019

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 Expiration Date: 01/09/2022
• Device Model Number: 00711155
• Device Catalogue Number: 00711155
• Device Lot Number: 1900301
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/23/2019
• Initial Report FDA Received Date: 03/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1