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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGIQUEST AIRSEAL IFS

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SURGIQUEST AIRSEAL IFS Back to Search Results
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.
 
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Brand Name
AIRSEAL IFS
Type of Device
AIRSEAL
Manufacturer (Section D)
SURGIQUEST
milford 06460
MDR Report Key4181947
MDR Text Key5098577
Report NumberMW5038611
Device Sequence Number1
Product Code HIF
Reporter Country CodeUS
Number of Events Reported1
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 Received10/09/2014
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age45 YR
Patient Weight61
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