FDA Adverse Event
Malfunction
Summary report: N
SNAKE LIVER RETRACTOR 5MM
MDR report key: 7955454
·
Received October 11, 2018
Report
- Report Number
- 7955454
- Event Type
- Malfunction
- Date Received
- October 11, 2018
- Date of Event
- May 11, 2018
- Report Date
- May 22, 2018
- Manufacturer
- ARTISAN MEDICAL
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE SNAKE RETRACTOR "BECOME" STUCK IN THE COILED POSITION AND HAD TO BE MANUALLY MANIPULATED THROUGH THE LAPAROSCOPIC PORT INSERTED IN THE PATIENT. NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 795686 | SNAKE LIVER RETRACTOR 5MM | RETRACTOR | GAD | ARTISAN MEDICAL | SNK-100 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27010 DA |