MAUDE Adverse Event Report: AUS SYSTEMS PTY LTD PROCEDURE PACK (CUTTER); INSTRUMENT, BIOPSY, SUCTION

Lot Number U22222

Patient Problem Insufficient Information (4580)

Event Date 11/03/2023

Event Type  malfunction  

Event Description

During a rectal biopsy, specimen was getting stuck in cartridge, but have not had the tissue get caught on patient side.

• Brand Name: PROCEDURE PACK (CUTTER)
• Type of Device: INSTRUMENT, BIOPSY, SUCTION
• Manufacturer (Section D): AUS SYSTEMS PTY LTD; 1123 north u.s. highway; victor MT 59875
• MDR Report Key: 18586574
• MDR Text Key: 333840171
• Report Number: 18586574
• Device Sequence Number: 1
• Product Code: FCK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/13/2023,11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: U22222
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/13/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 150 DA
• Patient Sex: Female