FDA Adverse Event
Malfunction
Summary report: N
PROCEDURE PACK (CUTTER)
MDR report key: 18586574
·
Received January 26, 2024
Report
- Report Number
- 18586574
- Event Type
- Malfunction
- Date Received
- January 26, 2024
- Date of Event
- November 3, 2023
- Report Date
- November 10, 2023
- Manufacturer
- AUS SYSTEMS PTY LTD
- Product Code
- FCK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OH
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
DURING A RECTAL BIOPSY, SPECIMEN WAS GETTING STUCK IN CARTRIDGE, BUT HAVE NOT HAD THE TISSUE GET CAUGHT ON PATIENT SIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1357096 | PROCEDURE PACK (CUTTER) | INSTRUMENT, BIOPSY, SUCTION | FCK | AUS SYSTEMS PTY LTD | U22222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 150 DA | Female | Other |