MAUDE Adverse Event Report: MICRO-TECH (NANJING) CO., LTD. LESIONHUNTER ROTATABLE NITINOL COLD SNARE; SNARE, SURGICAL

Model Number CS2-215232321

Patient Problem Foreign Body In Patient (2687)

Event Date 07/18/2023

Event Type  malfunction  

Event Description

While using the microtech lesionhunter rotatable nitinol cold snare, snare broke while inside the patient and needed to be retrieved with another device.This is the second occurrence of this happening at one of our facilities in the last 2 weeks.Product lot numbers are the same.M220403301 device id gs2-21523231.There was no harm to either patient.Reference report: #mw5119919.

• Brand Name: LESIONHUNTER ROTATABLE NITINOL COLD SNARE
• Type of Device: SNARE, SURGICAL
• Manufacturer (Section D): MICRO-TECH (NANJING) CO., LTD.
• MDR Report Key: 17381818
• MDR Text Key: 319878382
• Report Number: MW5119920
• Device Sequence Number: 1
• Product Code: GAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS2-215232321
• Device Catalogue Number: CS50060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1