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

Model Number ASU1200

Device Problems Sticking (1597); Aspiration Issue (2883)

Patient Problem No Information (3190)

Event Date 03/16/2018

Event Type  malfunction  

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 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.

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
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan road; waukegan IL 60086
• MDR Report Key: 7422084
• MDR Text Key: 105390730
• Report Number: 1423537-2018-00177
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10630140169694
• UDI-Public: 10630140169694
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ASU1200
• Device Catalogue Number: ASU1200
• Device Lot Number: 041719
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/16/2018
• Patient Sequence Number: 1