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

Model Number	ASU1200
Health Effect - Clinical Code	No Information (3190)
Date of Event	03/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was received and forward on to the manufacturing facility for investigation.The actual complaint product was requested, but not received for evaluation.The device history record for the reported lot has been reviewed for conformance to cardinal health specifications and the product does conform.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.Testing had been performed prior to final packaging and sterilization and met all requirements.We will continue to monitor and if the sample becomes available we will reopen the investigation.
Event or Problem Description
After several uses, the suction red switch remains depressed causing aspiration to continue.This causes a loss of pneumoperitoneum and a slowdown of the procedure.
Additional Manufacturer Narrative
No sample was received for evaluation therefore we are unable to confirm the issue report.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 june 11th 2018.

• Brand Name: PROBE 5MM X 33CM, DISP FIXED
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan road; waukegan IL 60086
• MDR Report Key: 7422084
• Report Number: 1423537-2018-00177
• Device Sequence Number: 11253702
• Product Code: GBX
• UDI-Device Identifier: 10630140169694
• UDI-Public: 10630140169694
• 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): 06/28/2018

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: ASU1200
• Device Catalogue Number: ASU1200
• Device Lot Number: 041719
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 06/28/2018
• Patient Sequence Number: 1