MAUDE Adverse Event Report: GYRUS ACMI IRRI-FLO II; IRRIGATION DELIVERY SYSTEM

Model Number 5920002

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

A gyrus acmi irri-flo ii irrigation delivery system was being used during procedure urology procedure by surgeon.When trying to use the device it was noticed that there was a hole in the body of the stopcock.A new device was used and the procedure was performed without further incident.Diagnosis or reason: laser lithotripsy.

• Brand Name: IRRI-FLO II
• Type of Device: IRRIGATION DELIVERY SYSTEM
• Manufacturer (Section D): GYRUS ACMI; southborough MA 01772
• MDR Report Key: 3639674
• MDR Text Key: 17566887
• Report Number: MW5034621
• Device Sequence Number: 1
• Product Code: KYZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 5920002
• Device Catalogue Number: 5920002
• Device Lot Number: MK788970
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR