FDA Adverse Event
Malfunction
Summary report: N
RBI2 SUCTION RECTAL BIOPSY SYSTEM
MDR report key: 20705393
·
Received November 18, 2024
Report
- Report Number
- 20705393
- Event Type
- Malfunction
- Date Received
- November 18, 2024
- Date of Event
- October 23, 2024
- Report Date
- October 28, 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
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2036401 | RBI2 SUCTION RECTAL BIOPSY SYSTEM | INSTRUMENT, BIOPSY, SUCTION | FCK | AUS SYSTEMS PTY. LIMITED. | RBI2 | 22409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 MO | Unknown |