inforMED
MalfunctionFCK

RBI2 SUCTION RECTAL BIOPSY SYSTEM

Received Nov 18, 2024 · Event occurred Oct 23, 2024

Report 20705393 · MDR key 20705393

Device

Generic name

Instrument, Biopsy, Suction

Model number

RBI2

Catalog number

CP1200

Lot number

22409

Patient

4 MO · Unknown

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

Narrative

Description of Event or Problem

WE DID CONFIRM WITH A DRY RUN THAT THE BLADE WOULD DEPLOY WHEN FIRED, HOWEVER WHEN ATTEMPTING TO GET A SPECIMEN EVEN AFTER THIS WE WERE UNABLE TO GET A BIOPSY SPECIMEN. WE SWITCHED THE GUN TO SUCTION RECTAL BIOPSY GUN #4 AND STILL HAD THE SAME ISSUE UNTIL ABOUT THE 3RD OR 4TH ATTEMPT WHEN THE GUN FINALLY WAS ABLE TO GET 2 SPECIMENS. IN EACH ATTEMPT AT BIOPSY, THE TRIGGER WAS PUSHED THE ENTIRE WAY TO THE METAL END SUCH THAT IT COULD NOT HAVE BEEN DEPLOYED FURTHER. MANUFACTURER RESPONSE FOR RB2 SUCTION RECTAL BIOPSY GUN AND DISPOSABLES, RBI2 (PER SITE REPORTER). AWAITING RESPONSE.