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

Model Number 00711119

Device Problem Entrapment of Device (1212)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/29/2020

Event Type  malfunction  

Manufacturer Narrative

The user reported the catheter was buckled near the handle, and reported no visible cautery effect.Actuation with excessive force, as suggested by the damage to the device catheter, can damage and disable the device, preventing retraction of the snare loop with electrocautery and removal from the tissue.The device subject of this event was not returned to steris endoscopy for evaluation.The user facility provided multiple lot numbers from which the device subject of this event may have originated but was unable to identify the specific lot.The device history records were reviewed and confirmed the device lots were manufactured to specification.There have been no other complaints associated with any of these lots.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." the distributor has offered in-service training to the user facility, and the user facility has accepted; however, the date has yet to be determined.No additional issues have been reported.

Event Description

The distributor reported that, during resection of a large polyp in the transverse colon, the snare loop of a lariat snare became entrapped in the polyp tissue.The user completed resection of the polyp with the use of another snare, and the initial snare was freed using forceps.A bleed at the site of the resection was reported, and was treated with the application of hemostatic clips.

• Brand Name: LARIAT SNARE
• Type of Device: POLYPECTOMY SNARE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, oh
• MDR Report Key: 10200757
• MDR Text Key: 198522673
• Report Number: 1528319-2020-00021
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K200745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00711119
• Device Catalogue Number: 00711119
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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