FDA Adverse Event
Malfunction
Summary report: N
LESIONHUNTER
MDR report key: 18391857
·
Received December 26, 2023
Report
- Report Number
- 18391857
- Event Type
- Malfunction
- Date Received
- December 26, 2023
- Date of Event
- October 20, 2023
- Report Date
- November 1, 2023
- Manufacturer
- MICRO-TECH (NAN JING) CO., LTD.
- Product Code
- GAE
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
A LESIONHUNTER SNARE BROKE DURING A POLYPECTOMY IN THE PATIENT. THE SNARE WAS REMOVED WITHOUT INCIDENT. SNARE SAVED FOR FUTURE EXAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1360312 | LESIONHUNTER | SNARE, SURGICAL | GAE | MICRO-TECH (NAN JING) CO., LTD. | M230413302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24090 DA | Female |