MAUDE Adverse Event Report: AUS SYSTEMS PTY LTD RBI2 SUCTION RECTAL BIOPSY SYSTEM

Model Number	RBI2
Medical Device Problem Codes	Misassembly by Users (3133); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Handpiece was sent back for evaluation.Upon receipt, it was found to be improperly assembled- specifically, the spring and locknut were inserted before the shaft, contrary to manufacturer specifications.This reassembly appears to have been done post-procedure by sterilization staff.The device was correctly reassembled by the manufacturer and tested with a capsule.The blade successfully actuated fully, indicating no functional defect with the device.User discussions revealed that clinical personnel may not have fully actuated the blade during the procedure, possibly contributing to the incident.The manufacturer is initiating retraining efforts to reinforce correct assembly and actuation techniques.The device operated as intended when correctly assembled.The probable root cause is user error due to incomplete blade actuation or improper handling.
Event or Problem Description
Blade stopped halfway through, got stuck and the general surgery team was called in to remove the blade and suture the patient.

• Brand Name: RBI2 SUCTION RECTAL BIOPSY SYSTEM
• Common Device Name: RBI2
• Manufacturer (Section D): AUS SYSTEMS PTY LTD; 3; charles street; allenby gardens, south australia 5009 ; AS 5009
• Manufacturer (Section G): AUS SYSTEMS PTY LTD; 3; charles street; allenby gardens, south australia 5009 ; AS 5009
• Manufacturer Contact: paul zadow ; 3; charles street; allenby gardens, south australia 5009 ; AS 5009
• MDR Report Key: 22041055
• Report Number: 3005921952-2025-00001
• Device Sequence Number: 12986483
• Product Code: FCK
• UDI-Device Identifier: B194CP12001
• UDI-Public: +B194CP12001/$$7U22318/16D20231018/14D202810163
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K062159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: RBI2
• Device Catalogue Number: HP1000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown