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

Model Number	SE3690
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Event or Problem Description
While using the covidien smoke evacuator, it was not working consistently.Smoke evac just stops working with no explanation.Staff in room breathing in large amounts of plume from case.All cables, connections, filters, and the bovie itself checked; no apparent reason for smoke evac to be working only intermittently.

• Brand Name: RAPIDVAC
• Common Device Name: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8784755
• Report Number: 8784755
• Device Sequence Number: 13963814
• Product Code: FYD
• UDI-Device Identifier: 10884524001555
• UDI-Public: (01)10884524001555
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/14/2019
• Report Date (Section F): 06/14/2019

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
• Device Catalogue Number: SE3690
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 06/14/2019