FDA Adverse Event
Injury
Summary report: N
ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE
MDR report key: 12985009
·
Received December 13, 2021
Report
- Report Number
- 3005580113-2021-00152
- Event Type
- Injury
- Date Received
- December 13, 2021
- Date of Event
- November 11, 2021
- Report Date
- December 13, 2021
- Manufacturer
- COOK IRELAND LTD
- Product Code
- FCG
- UDI-DI
- 10827002342818
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
FCG KIT, NEEDLE, BIOPSY.
Additional Manufacturer Narrative · 0
FCG KIT, NEEDLE, BIOPSY.
Description of Event or Problem · 0
ACCORDING TO THE INITIAL REPORTER, "THE NEEDLE BROKE OFF IN THE PATIENT. USER WAS ABLE TO RETRIEVE BROKEN PIECE."
Description of Event or Problem · 0
ACCORDING TO THE INITIAL REPORTER, "THE NEEDLE BROKE OFF IN THE PATIENT. USER WAS ABLE TO RETRIEVE BROKEN PIECE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1884614 | ECHOTIP PROCORE ENDOBRONCHIAL HD BIOPSY NEEDLE | FCG | COOK IRELAND LTD | C1857949 | 10827002342818 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |