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

Model Number 00711119

Device Problem Entrapment of Device (1212)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

The user reported the snare had been actuated with force causing the catheter to buckle near the handle, and reported no visible cautery effect.Actuation with excessive force can damage and disable the device, preventing retraction of the snare loop with electrocautery and removal from the tissue.The handle and catheter portions of the lariat snare subject of the reported event were returned to us endoscopy for evaluation.Examination of the returned portions found a significant buckle of the catheter, consistent with the user report of buckling following the application of excessive force.The drive cable and snare loop portions were not returned, consequently the electrocautery function could not be evaluated.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.The instructions for use include the following statements: the following conditions may not allow the lariat snare device to function properly: advancing the handle to the open position with too much speed or force, 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.To prevent inadvertent injury to the patient, avoid forcefully closing the device without adequate electrocoagulation.A us endoscopy representative has provided in-service training including instruction on use of snare without excessive force.No additional issues have been reported.

Event Description

The user facility reported that, during piecemeal resection of a 7-8 cm polyp in the colon, the snare loop of a lariat snare became entrapped in the polyp tissue.The user attempted to disengage the snare from the polyp without success and an additional procedure was required to remove the snare and complete the polypectomy.The patient is reported to be well.

• Brand Name: LARIAT SNARE
• Type of Device: POLYPECTOMY SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 8825832
• MDR Text Key: 156588533
• Report Number: 1528319-2019-00029
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 00816765012550
• UDI-Public: (01)00816765012550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2022
• Device Model Number: 00711119
• Device Catalogue Number: 00711119
• Device Lot Number: 1820674
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2019
• Initial Date FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2019
• 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