MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. TRAXTION HEXAGONAL SNARE; POLYPECTOMY SNARE

Model Number	00711113
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the reported failure to deliver diathermic energy, the user then attempted to cut the polyp using the traxtion snare without electrocautery.The attempt without electrocautery resulted in a mucosal tear at the polypectomy site.This is contrary to the instructions for use as the traxtion snare is intended for use only with diathermic energy.The subject device was then replaced with a different hot snare not manufactured by us endoscopy and the polypectomy was completed.Hemostasis clips were placed at the site to close the mucosal tear.The traxtion snare subject of the reported event was returned to us endoscopy for evaluation.Us endoscopy could not confirm the reported event, as examination of the device proved electrical continuity through the device, and the device had no evidence of burning or heat discoloration.Catheter deformation was observed, indicative of excess force applied during use which is consistent with the user report of attempted use without electrocautery.The user facility was not able to provide the lot number of the traxtion snare subject of this event.The instructions for use include the following statements: these devices are used with diathermic energy.Disengage the snare from the polyp if there is a risk of complication.If there is a lack of visible cautery effect, consider the following: check the active cord for secure connection to the snare handle and the electrosurgical generator.Ensure that the return electrode is secure and properly connected to the patient and the electrosurgical generator.Consult the electrosurgical generator manufacturer's instructions for use for proper settings and use of the generator.In order to ensure that the insulating properties of the monopolar diathermic snares are not compromised, do not exceed the maximum rated peak voltage of 2500 for cut mode and 2500 for coagulation mode.Us endoscopy has offered in-service training to the user facility; however, the user facility has declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that, during a polypectomy procedure, a traxtion snare failed to deliver electrocautery and that a burning odor was detected.The procedure was completed using a different hot snare, and hemostasis clips were placed at the polypectomy site following the reported event.The patient is reported to be well, with no further issues resulting from this event.

• Brand Name: TRAXTION HEXAGONAL SNARE
• Common Device Name: POLYPECTOMY SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8809398
• Report Number: 1528319-2019-00028
• Device Sequence Number: 14168078
• Product Code: FDI
• UDI-Device Identifier: 00816765010990
• UDI-Public: (01)00816765010990
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K924105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: 00711113
• Device Catalogue Number: 00711113
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1