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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN RAPIDVAC; APPARATUS, EXHAUST, SURGICAL
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COVIDIEN RAPIDVAC; APPARATUS, EXHAUST, SURGICAL Back to Search Results
Model Number SE3690
Device Problems Decrease in Suction (1146); Structural Problem (2506); Intermittent Energy Output (4025)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2022
Event Type  malfunction  
Event Description
During a surgical procedure, this smoke evacuator (one of two that failed during same procedure) was working intermittently during the case.Unit was restarted and the same issue was occurring.The unit was removed from service and a second unit was set up.Also have noted that the handpieces for the units do not capture smoke very well and the handpieces are large which makes it hard for the surgeons to see what they are doing.No adverse outcome to patient, there was an increase in the amount of smoke in the or room.
 
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Brand Name
RAPIDVAC
Type of Device
APPARATUS, EXHAUST, SURGICAL
Manufacturer (Section D)
COVIDIEN
5920 longbow drive
boulder CO 80301
MDR Report Key16240044
MDR Text Key308082595
Report Number16240044
Device Sequence Number1
Product Code FYD
UDI-Device Identifier10884524001555
UDI-Public10884524001555
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/10/2023
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 Model NumberSE3690
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/10/2023
Device Age53 MO
Event Location Hospital
Date Report to Manufacturer01/25/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/25/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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