MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. SHORT THROW SNARE - ENTERSCOPE; POLYPECTOMY SNARE

Model Number 00711101

Device Problems Bent (1059); Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 10/31/2014

Event Type  No Answer Provided  

Event Description

Us endoscopy received a report of procedural delay associated with short throw snare - enteroscope ((b)(4)).Follow up information provided by the user explained the event occurred during an enteroscopy procedure, with the endoscope positioned in a tortuous configuration.The procedure was attempted with four snares.In each attempt, the snare was functional before use.In each attempt, the device; however, failed to deploy during procedural use, and the user described wire bending at the handle.The procedure was subsequently cancelled.

Manufacturer Narrative

Device deployment can be affected by clinical usage challenges, such as tortuous pathways.The instructions for use include 'use of excessive force can render the device inoperable.The user's description of wire bending at the handle indicates use of excessive force, as associated with deployment in a tortuous configuration.A review of the lot history record indicates no anomalies in the manufacture of the lot.The device will be subject to a physical examination upon return.This report will be updated if additional information becomes available.

• Brand Name: SHORT THROW SNARE - ENTERSCOPE
• Type of Device: POLYPECTOMY SNARE
• Manufacturer (Section D): 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: 4294081
• MDR Text Key: 5079599
• Report Number: 1528319-2014-00025
• Device Sequence Number: 1
• Product Code: FDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 00711101
• Device Catalogue Number: 00711101
• Device Lot Number: 80162
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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
• Patient Outcome(s): Other