MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. LARIAT SNARE

Model Number	00711119
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event has not been returned to steris endoscopy for evaluation.Statements from the instructions for use packet include, "the following conditions may not allow the lariat® snare device to function properly: (1) advancing the handle to the open position with too much speed or force, (2) attempting to pass or open the device in an extremely articulated endoscope, (3) attempting to actuate the device in an extremely coiled position and/or (4) actuating the device when the handle is at an acute angle in relation to the sheath.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 dispersive electrode is properly applied to the patient and securely attached to the electrosurgical generator.(3) consult the electrosurgical generator manufacturer's instructions for use for proper settings and use of the generator.(4) caution: 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." a steris quality systems specialist offered in-service training on the proper use of the lariat snare; however, steris is awaiting a response.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch mw5111242 that their lariat snare became entrapped in the polyp during procedural use.It was reported that an additional snare was used to free the snare and the procedure was rescheduled for completion at a later date.No report of injury.
Additional Manufacturer Narrative
During the week of (b)(6) 2022, a steris endoscopy product specialist conducted in-servicing training on the proper use of the lariat snare.The user facility has since discontinued use of the lariat snare.No additional issues have been reported.

• Brand Name: LARIAT SNARE
• Common Device Name: LARIAT SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 15303818
• Report Number: 1528319-2022-00042
• Device Sequence Number: 6360723
• Product Code: FDI
• UDI-Device Identifier: 00724995182632
• UDI-Public: 00724995182632
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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: 00711119
• Device Catalogue Number: 00711119
• Device Lot Number: 2201659
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown