inforMED
MalfunctionFCK

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

Model number

RBI2

Catalog 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.