MAUDE Adverse Event Report: COVIDIEN LP RAPIDVAC; APPARATUS, EXHAUST, SURGICAL

Model Number	SE3690
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During a surgical procedure, this smoke evacuator (two 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.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.

• Brand Name: RAPIDVAC
• Common Device Name: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 16240030
• Report Number: 16240030
• Device Sequence Number: 6523174
• Product Code: FYD
• UDI-Device Identifier: 10884524001555
• UDI-Public: 10884524001555
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2023
• Report Date (Section F): 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
• Operator of Device: Health Professional
• Device Model Number: SE3690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 57 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/25/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/10/2023