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

Model Number CS2-21023231

Patient Problem Foreign Body In Patient (2687)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

During a colonoscopy, there was a polyp found, we opened a cold snare.While trying to remove the polyp with the snare, the tip of the snare broke off.It was retrieved from the patient and sequestered.The staff in the room opened a different type of snare and was able to remove the polyp.There was no harm to the patient.

• Brand Name: MICRO-TECH LESION HUNTER
• Type of Device: SNARE, SURGICAL
• Manufacturer (Section D): MICRO TECH (NAN JING) CO., LTD.; CH
• MDR Report Key: 17949588
• MDR Text Key: 326005709
• Report Number: MW5147024
• 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: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CS2-21023231
• Device Catalogue Number: CS50050
• Device Lot Number: M230604307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LESION HUNGER. THERAPY START AND END DATE.
• Patient Age: 75 YR
• Patient Sex: Female