MAUDE Adverse Event Report: MICROTECH (NAN JING) CO., LTD. MICRO-TECH LESION HUNTER COLD SNARE; SNARE, SURGICAL

Catalog Number CS2-21023231

Device Problem Detachment of Device or Device Component (2907)

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

Event Description

Micro-tech lesion hunter cold snare wire loop broke free from device during use.A 45 year old male scheduled for colonoscopy undergoing routine polypectomy.During insertion of cold snare, after opening wire loop it broke free from device.(micro-tech lesion hunter cold snare, lot# m220410302, exp:4/9/2024, ref# cs2-21023231) snare was removed from scope and wire loop retrieved by endoscopist without complication.Polyp removed and procedure completed without further incident.There was no harm to the patient.

• Brand Name: MICRO-TECH LESION HUNTER COLD SNARE
• Type of Device: SNARE, SURGICAL
• Manufacturer (Section D): MICROTECH (NAN JING) CO., LTD.; nan jing jiangsu CN 21 0032; CH CN 210032
• MDR Report Key: 16446286
• MDR Text Key: 310362553
• Report Number: MW5115232
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2024
• Device Catalogue Number: CS2-21023231
• Device Lot Number: M220410302
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR