MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC; SUCTION IRRIGATOR

Catalog Number ASU1200

Device Problems Device Remains Activated (1525); Suction Problem (2170)

Patient Problem No Code Available (3191)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

Suction irrigator malfunctioned during total laparoscopic hysterectomy.Suction irrigator would not stop suctioning after suction button was released caused a loss in co2 in the abdomen.Malfunctioning suction irrigator removed from field and replaced with new one.

• Type of Device: SUCTION IRRIGATOR
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 1500 waukegan road; waukegan IL 60085
• MDR Report Key: 4938361
• MDR Text Key: 18724677
• Report Number: 4938361
• Device Sequence Number: 1
• Product Code: GCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: ASU1200
• Device Lot Number: 0000763574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR