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

Model Number	00711110
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of this complaint was returned to steris endoscopy for evaluation.The device was cut by the user and therefore functional testing was not possible.Examination of returned device showed damage to the device sheath.The device history record was reviewed and confirmed the device lot was manufactured to specification.There have been no other complaints associated with this lot.Statements in the instructions for use include: "the following conditions may not allow the cointip snare to function properly: advancing the handle to the open position with too much speed or force, attempting to insert or actuate the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or, actuating the device while the handle is at an acute angle in relation to the sheath.To avoid kinking the catheter, use only short strokes, 1"-1.5" (2.5 cm - 3.8 cm) in length, throughout device insertion." steris endoscopy has offered in-service training on the use of the cointip snare to the user facility; however, the facility has declined.No further issues have been reported.
Event or Problem Description
The user facility reported that a cointip snare failed to cut a polyp and became entrapped.The user adjusted electrocautery settings and successfully cut the polyp using a second snare, freeing the initial snare.Following the reported event, a clip was placed at the polypectomy site as a precautionary measure.

• Brand Name: COIN TIP SNARE
• Common Device Name: SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 11477486
• Report Number: 1528319-2021-00008
• Device Sequence Number: 11723506
• Product Code: FDI
• UDI-Device Identifier: 00724995194369
• UDI-Public: (01)00724995194369
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K200745
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/12/2021

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 Expiration Date: 06/29/2023
• Device Model Number: 00711110
• Device Catalogue Number: 00711110
• Device Lot Number: 2006211
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1