FDA Adverse Event
Malfunction
Summary report: N
RBI2 SUCTION RECTAL BIOPSY SYSTEM
MDR report key: 20662499
·
Received November 12, 2024
Report
- Report Number
- 20662499
- Event Type
- Malfunction
- Date Received
- November 12, 2024
- Date of Event
- September 27, 2024
- Report Date
- October 7, 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
SUCTION RECTAL BIOPSY WAS PERFORMED SUCCESSFULLY TWICE (X2). ON THE THIRD ATTEMPT, AFTER TRIGGERING THE SUCTION RECTAL BIOPSY GUN, THERE WAS A CLICKING NOISE. THE CAPSULE WAS UNABLE TO BE REMOVED FROM PATIENT'S RECTUM AND FOUND TO BE STUCK ON RECTAL MUCOSA. MD AND PEDIATRIC SURGEON FELLOW NOTIFIED. SHE ATTEMPTED TO FLUSH AND PROBE THE CAPSULE. AFTER ABOUT 40 MINUTES, IT WAS SUCCESSFULLY REMOVED AFTER PATIENT STOOLED ON THEIR OWN. NO TISSUE NOTED IN CARTRIDGE ON REMOVAL. NO BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1134899 | RBI2 SUCTION RECTAL BIOPSY SYSTEM | INSTRUMENT, BIOPSY, SUCTION | FCK | AUS SYSTEMS PTY. LIMITED. | RBI2 | U22318 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |