FDA Adverse Event
Malfunction
Summary report: N
ETHICON LXMC15 LINX DEVICE
MDR report key: 20268310
·
Received September 19, 2024
Report
- Report Number
- MW5159791
- Event Type
- Malfunction
- Date Received
- September 19, 2024
- Date of Event
- September 6, 2024
- Report Date
- September 16, 2024
- Manufacturer
- ETHICON ENDO-SURGERY, INC.
- Product Code
- QJN
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- AL, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE LINX DEVICE DISRUPTED. THE MODEL NUMBER WAS LXMC15. LOT # 10240. SERIAL NUMBER (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1449442 | ETHICON LXMC15 LINX DEVICE | LAPAROSCOPIC ACCESSORIES, ESOPHAGEAL SIZING | QJN | ETHICON ENDO-SURGERY, INC. | 10240 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Male | Other |