FDA Adverse Event
Malfunction
Summary report: N
RBI2 SUCTION RECTAL BIOPSY SYSTEM
MDR report key: 20705444
·
Received November 18, 2024
Report
- Report Number
- 20705444
- Event Type
- Malfunction
- Date Received
- November 18, 2024
- Date of Event
- October 24, 2024
- Report Date
- October 28, 2024
- Manufacturer
- AUS SYSTEMS PTY. LIMITED.
- 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
PATIENT UNDERGOING SUCTION RECTAL BIOPSY. FIRST TWO TISSUES SPECIMENS OBTAINED WITH NO ISSUES. ON THE THIRD ATTEMPT, AFTER TRIGGERING THE BIOPSY DEVICE, THE CARTRIDGE WAS UNABLE TO BE REMOVED FROM PATIENT'S ANUS. THE BIOPSY DEVICE WAS REMOVED AND CARTRIDGE WAS STILL UNABLE TO BE REMOVED FROM PATIENT'S ANUS AND APPEARED TO BE CAUGHT ON TISSUE. FELLOW WAS CALLED TO BEDSIDE. BIOPSY DEVICE WAS REINSERTED AND TRIGGER WAS PULLED AGAIN. THE BIOPSY DEVICE ALONG WITH THE CARTRIDGE WAS THEN EASILY REMOVED. SMALL AMOUNT OF BLEEDING NOTED IN DIAPER. TISSUE SAMPLE WAS REMOVED FROM CARTRIDGE AND SENT TO LAB WITH THE FIRST TWO TISSUE SAMPLE. MANUFACTURER RESPONSE FOR SUCTION RECTAL BIOPSY CAPSULE, RBI2 (PER SITE REPORTER). AWAITING RESPONSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2089816 | RBI2 SUCTION RECTAL BIOPSY SYSTEM | INSTRUMENT, BIOPSY, SUCTION | FCK | AUS SYSTEMS PTY. LIMITED. | RBI2 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Unknown |