MAUDE Adverse Event Report: STRYKER STRYKER; PNEUMOSURE HIGH FLOW HEATED INSUFFLATION TUBING

Model Number 0620-040-690

Device Problem Insufficient Heating (1287)

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

Event Type  malfunction  

Event Description

Stryker pneumosure high flow heated insufflation tubing stopped heating co2 gas.Insufflator was giving an error for "no heat." new tubing was passed to sterile field and connected to pneumosure machine and heated gas without incident.

• Brand Name: STRYKER
• Type of Device: PNEUMOSURE HIGH FLOW HEATED INSUFFLATION TUBING
• Manufacturer (Section D): STRYKER; 2825 airview blvd.; kalamazoo MI 49002
• MDR Report Key: 5127452
• MDR Text Key: 27531591
• Report Number: MW5056812
• Device Sequence Number: 1
• Product Code: HIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other

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
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: 0620-040-690
• Device Lot Number: 15C0114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1