MAUDE Adverse Event Report: SURGIQUEST AIRSEAL IFS

Device Problem Insufficient Information (3190)

Patient Problems Keratitis (1944); Complaint, Ill-Defined (2331)

Event Date 06/18/2014

Event Type  Injury  

Event Description

Pt underwent an uneventful total laparoscopic hysterectomy using a da vinci robot.A surgiquest airseal ifs device was used to maintain pneumoperitoneum.No problems were noted during post operative recovery and she was sent home later that day per our usual protocol.The pt first noted symptoms of what turned out to be subcutaneous emphysema in her neck later in the evening.She was seen in the office post op day #2 and had subcutaneous emphysema from her neck to her knees.She did not have any respiratory symptoms of cough or shortness of breath.Her symptoms steadily improved but 6 weeks after surgery she complained of persistent pain behind her knees when bending.

• Brand Name: AIRSEAL IFS
• Type of Device: AIRSEAL
• Manufacturer (Section D): SURGIQUEST; milford 06460
• MDR Report Key: 4181947
• MDR Text Key: 5098577
• Report Number: MW5038611
• 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: Physician
• Type of Report: Initial
• Report Date: 10/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 61