MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. SHORT THROW SNARE - MINI-OVAL

Model Number	00711018
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure their short throw snare - mini oval failed to cut a polyp and a piece of the snare broke off.The broken piece of the snare was retrieved and removed endoscopically with forceps.No report of patient harm.
Additional Manufacturer Narrative
The device subject of the event was not returned for evaluation.Without the returned device the root cause of the reported event cannot be determined.The short throw snare mini oval instructions for use states, "the following conditions may not allow a snare device to function properly: advancing the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or 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: 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.Observe for whitening of the tissue as visible evidence of electrocoagulation".The device history record was reviewed and no abnormalities were identified.A three-year complaint review for this lot indicates this to be an isolated event.No additional issues were noted.

• Brand Name: SHORT THROW SNARE - MINI-OVAL
• Common Device Name: 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: 14172162
• Report Number: 1528319-2022-00022
• Device Sequence Number: 5011399
• Product Code: FDI
• UDI-Device Identifier: 00724995182472
• UDI-Public: 00724995182472
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/21/2022

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 Model Number: 00711018
• Device Catalogue Number: 00711018
• Device Lot Number: 2201284
• 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: 03/23/2022
• Initial Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2022
• 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