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

Lot Number M230413302

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2023

Event Type  malfunction  

Event Description

A lesionhunter snare broke during a polypectomy in the patient.The snare was removed without incident.Snare saved for future examination.

• Brand Name: LESIONHUNTER
• Type of Device: SNARE, SURGICAL
• Manufacturer (Section D): MICRO-TECH (NAN JING) CO., LTD.; 2855 broadway dr.; ann arbor MI 48104
• MDR Report Key: 18391857
• MDR Text Key: 331298509
• Report Number: 18391857
• Device Sequence Number: 1
• Product Code: GAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: M230413302
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/26/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24090 DA
• Patient Sex: Female