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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONMED CORPORATION AIRSEAL IFS SYSTEM SURGIQUEST; INSUFFLATOR, LAPAROSCOPIC
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CONMED CORPORATION AIRSEAL IFS SYSTEM SURGIQUEST; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 07/10/2019
Event Type  malfunction  
Event Description
A new airseal ifs system was to be used for surgical procedure and the standard process was followed to prepare the airseal ifs system for the transanal minimally invasive surgery (tamis) procedure.Prior to using, error code: "valve error call service." company service was called from or room.Followed service representative's directions.This was a major fault and not operational.Surgeon had to use co2 directly from the laparoscopic machine to insufflate the rectum.This worked, but was less than optimal.The airseal ifs system was brought to the biomedical engineering department.The manufacturer is sending a new replacement system via overnight delivery.Manufacturer response for airseal ifs system surgiquest, airseal ifs system surgiquest (per site reporter).Replacement of the new non-functioning ifs system.
 
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Brand Name
AIRSEAL IFS SYSTEM SURGIQUEST
Type of Device
INSUFFLATOR, LAPAROSCOPIC
Manufacturer (Section D)
CONMED CORPORATION
525 french rd
utica NY 13502
MDR Report Key8793069
MDR Text Key151121217
Report Number8793069
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2019
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2019
Event Location Hospital
Date Report to Manufacturer07/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age21900 DA
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