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

Model Number 00711110

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/29/2022

Event Type  malfunction  

Manufacturer Narrative

The device subject of the reported event and four unused devices from the same lot were returned for evaluation.Evaluation of the subject device found that the drive cable had multiple kinks, indicative of excessive force being used while operating the device.The cable assembly had separated from the connector, which may have interrupted cauterization and contributed to the reported event.The other four unused devices were evaluated, and no issues were noted.There have been no other complaints associated with this lot and is considered to be an isolated event.The instruction for use packet (ifu 733028) gives the user the following information when using the cointip¿ snare "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.Athorough understanding of the technical principles, clinical applications, and risks associated with monopolar diathermic energy and/or cold snaring (non-electrical) polypectomy and tissue resection is necessary before using this product.Endoscopic polypectomy with monopolar diathermic snares should not be performed without a thorough understanding of the principles of diathermic energy.To avoid kinking the catheter, use only short strokes, 1"-1.5" (2.5 cm - 3.8 cm) in length, throughout device insertion." steris performed in-service training on the proper use and operation of the cointip snare.No additional issues have been reported.

Event Description

The user facility reported via medwatch (mw5111836) report that during a colonoscopy procedure the handle of their cointip snare broke during cauterization subsequently causing the snare to become stuck on the polyp.The physician was able to loosen the snare and remove the polyp.No report of injury.

• Brand Name: COIN TIP SNARE
• Type of Device: 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: 15555119
• MDR Text Key: 306588526
• Report Number: 1528319-2022-00049
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00724995194369
• UDI-Public: 00724995194369
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00711110
• Device Catalogue Number: 00711110
• Device Lot Number: 2007137
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1