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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; PROBE, RADIOFREQUENCY LESION
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AVANOS MEDICAL, INC. AVANOS; PROBE, RADIOFREQUENCY LESION Back to Search Results
Model Number MCKA2-17-100-4
Device Problems Fluid/Blood Leak (1250); Component Missing (2306); Defective Device (2588)
Patient Problem Insufficient Information (4580)
Event Date 03/17/2022
Event Type  malfunction  
Event Description
Just prior to the procedure during radiofrequency ablation, the scrub tech realized the drapes were getting wet.All connections were checked and tight, and then it was noticed that the fluid tubing itself had a section missing and was draining directly onto the drape.The procedure was paused and a new coolief kit was opened to replace the defective tubing.Site emailed pictures to rep, no pictures available to attach to this report.Manufacturer response for cooled radiofrequency probe, collief multi probe kit radio frequency halyar 100 mm (per site reporter): clinical site notified manufacturer directly.
 
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Brand Name
AVANOS
Type of Device
PROBE, RADIOFREQUENCY LESION
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key14591646
MDR Text Key293266983
Report Number14591646
Device Sequence Number1
Product Code GXI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMCKA2-17-100-4
Device Catalogue NumberMCKA2-17-100-4
Device Lot Number30146237
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/27/2022
Event Location Hospital
Date Report to Manufacturer06/03/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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