rbi2 suction rectal biopsy systemRecalls & reported problems
Aus Systems Pty. Limited. · rbi2 suction rectal biopsy procedure pack · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B194CP12001), received between May 17, 2025 and May 17, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Misassembly by Users” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Misassembly by Users1
- No Apparent Adverse Event1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 17, 2025Misassembly by Users; No Apparent Adverse Event; Misassembly by Users; No Apparent Adverse Event
BLADE STOPPED HALFWAY THROUGH, GOT STUCK AND THE GENERAL SURGERY TEAM WAS CALLED IN TO REMOVE THE BLADE AND SUTURE THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22041055 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.