RBI2 SUCTION RECTAL BIOPSY SYSTEM
Received Nov 18, 2024 · Event occurred Oct 24, 2024
Report 20705444 · MDR key 20705444
Device
Generic name
Instrument, Biopsy, Suction
Manufacturer
Aus Systems Pty. Limited.Model number
RBI2Catalog number
CP1200
Patient
1 MO · Unknown
- Hemorrhage/Blood Loss/Bleeding
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
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.