FDA Adverse Event
Malfunction
Summary report: N
HARRELL BRONCHOSCOPE
MDR report key: 18858000
·
Received March 6, 2024
Report
- Report Number
- MW5152454
- Event Type
- Malfunction
- Date Received
- March 6, 2024
- Date of Event
- February 27, 2024
- Report Date
- March 4, 2024
- Manufacturer
- CONMED CORPORATION
- Product Code
- GEE
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
HARRELL BRONCHOSCOPE UNSHEATHED CYTOLOGY BRUSH - REF # 000140, LOT # 202304184, EXP 04/16/2028. - BRUSH HEAD CAME OFF INSIDE PT'S LEFT LOWER LOBE. DR. (B)(6) RETRIEVED IT USING ION CATH, PULMONARY FORCEPS AND THERAPUTIC BRONCHSCOPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159833 | HARRELL BRONCHOSCOPE | BRUSH, BIOPSY, GENERAL & PLASTIC SURGERY | GEE | CONMED CORPORATION | CONMED CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |