MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. ISNARE SYSTEM - LARIAT SNARE; POLYPECTOMY SNARE

Model Number	00711084
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the device history record indicates no issues during manufacture; the device was manufactured to specification.The subject device was returned to us endoscopy.Review of the device found it to be in proper working order.The instructions for use contain the following " if there is lack of visible cautery effect, consider the following: 1) check the active cord for secure connection to the snare handle and the electrosurgical generator.2) ensure that the return electrode is secure and properly connected to the patient and the electrosurgical generator.3) consult the electrosurgical generator manufacturer's instructions for use for proper settings and use of the generator.4) 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." "caution - output power setting of the electrosurgical unit should be set as low as possible to achieve the intended purpose.If the power setting of the generator is not known, set the power level at the minimum value of the expected range and cautiously increase power to achieve the desired tissue effect." continuing education training is being provided to the customer.
Event or Problem Description
The user facility reported incomplete resection during a polypectomy procedure which included use of the isnare lariat.Following the polypectomy a clip was placed at the site.

• Brand Name: ISNARE SYSTEM - LARIAT SNARE
• Common Device Name: POLYPECTOMY SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7118344
• Report Number: 1528319-2017-00040
• Device Sequence Number: 1119292
• Product Code: FDI
• UDI-Device Identifier: 00816765012741
• UDI-Public: (01)00816765012741(17)201016(11)171017(10)1717167
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K152035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/14/2017

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: No Information
• Device Expiration Date: 10/16/2020
• Device Model Number: 00711084
• Device Catalogue Number: 00711084
• Device Lot Number: 1717167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2017
• Initial Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention