inforMED
MalfunctionFCK

RBI2 SUCTION RECTAL BIOPSY SYSTEM

Received Dec 14, 2024 · Event occurred Oct 24, 2024

Report 3005921952-2024-00006 · MDR key 20934264

Device

Generic name

Rbi2

Model number

RBI2

Catalog number

CP1200

Lot number

NOT PROVIDED

Product problems

  • No Apparent Adverse Event
  • Appropriate Device Problem Term/Code Not Available
  • No Apparent Adverse Event
  • Appropriate Device Problem Term/Code Not Available

Patient

1 MO · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE INCIDENT LIKELY RESULTED FROM USER ERROR, SPECIFICALLY PRESSURE AGAINST MUCOSA WALL AND NOT IN A NEUTRAL POSITION AND INSUFFICIENT UNDERSTANDING OF OPERATIONAL PROCEDURES, INCLUDING SUCTION RELEASE TIMING.

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.