FDA Adverse Event
Malfunction
Summary report: N
ENCOR DRIVER
MDR report key: 16483380
·
Received March 4, 2023
Report
- Report Number
- 2020394-2023-00135
- Event Type
- Malfunction
- Date Received
- March 4, 2023
- Date of Event
- February 6, 2023
- Report Date
- February 22, 2023
- Manufacturer
- BARD PERIPHERAL VASCULAR, INC.
- Product Code
- KNW
- UDI-DI
- 00801741086076
- PMA / PMN Number
- K040842
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
AS THE SERIAL NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRATION DATE: 12/2050).
Description of Event or Problem · 0
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, WHILE TRYING TO DEPLOY THE MARKER, THE SYSTEM ALLEGEDLY TOOK TWO FURTHER SAMPLES WITHOUT PRESSING/SELECTING ANYTHING ON THE ENCOR SYSTEM, DRIVER OR FOOT PEDAL. ADDITIONALLY, IT WAS ALSO REPORTED THAT THERE WAS AN UNUSUAL SOUND COMING FROM THE DRIVER. THERE WAS NO REPORTED PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 515488 | ENCOR DRIVER | BIOPSY EQUIPMENT | KNW | BARD PERIPHERAL VASCULAR, INC. | DRENCOR | 00801741086076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |