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

Model Number ASU1200

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 01/08/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint was received and forwarded on to the manufacturing facility for investigation.Two lot numbers (031751 & 041720) were involved in this reported incident.The first lot number 031751 was manufactured on 3/23/2017 and the second lot number 041720 was manufactured on 6/29/2017.The device history records(dhrs) for both lot numbers were reviewed for conformance to the cardinal health specifications.The products are tested 100% for leaks.Specifically the ¿red button¿ is depressed, opened and closed several times during the test for leaks, and visual integrity appears to be in conformance.The product dhrs conforms to cardinal health specifications.Testing were performed prior to final packaging and sterilization and met requirements.If the products are returned in the future, they will be physically evaluated and a follow-up report filed.

Event Description

The suction tube with trumpet was being used during a total laparoscopic hysterectomy.The red button of the trumpet valve did not work correctly.

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 june 11th 2018.

• Brand Name: PROBE 5MM X 33CM, DISP FIXED
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 1500 waukegan rd; waukegan IL 60085
• MDR Report Key: 7245415
• MDR Text Key: 99824212
• Report Number: 1423537-2018-00151
• 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,health pr
• 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: 02/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ASU1200
• Device Catalogue Number: ASU1200
• Device Lot Number: 031751 & 041720
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2018
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention