MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC PROBE 5MM X 33CM, DISP FIXED; CATHETER, IRRIGATION

Model Number	ASU1201
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the above lot has been reviewed for conformance to the cardinal health specifications.The product is tested 100% for leaks.Specifically the ¿aspiration button¿ is depressed, opened and closed several times during the test for leaks, and visual integrity appears to be in conformance.There has been no other complaint from this lot.The product dhr conforms to cardinal health specifications.Testing had been performed prior to final packaging and sterilization and met all requirements.Follow up report will be submitted once investigation has been completed.
Event or Problem Description
Hepatectomy in laparoscopy procedure.Hydroline probes tested prior to be use and were reported to be functional, but after few pressures the valve became defective.3 different probes used on the same patient.The suction piston has been completely blocked 3 times in a row with 3 different devices during an intervention.
Additional Manufacturer Narrative
We are unable to confirm the issue reported.However, cardinal health has become aware of an issue in which the hydroline and pulse wave trumpet valves may not close properly, which could cause continuous suction.There is a remote possibility that inability to control suction during a procedure may result in loss of carbon dioxide in the abdomen, reduced visibility of the surgical site and potential injury to organs and body tissue.Cardinal health has issued a voluntary recall that was initiated on (b)(6) 2018.

• Brand Name: PROBE 5MM X 33CM, DISP FIXED
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan rd; waukegan IL 60085
• MDR Report Key: 7518918
• Report Number: 1423537-2018-00202
• Device Sequence Number: 1862776
• Product Code: GBX
• UDI-Device Identifier: 10630140169700
• UDI-Public: 10630140169700
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: ASU1201
• Device Catalogue Number: ASU1201
• Device Lot Number: 041727
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 04/19/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 06/25/2018
• Patient Sequence Number: 1