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

Model Number SE3690

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2019

Event Type  malfunction  

Event 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
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8784755
• MDR Text Key: 150843430
• Report Number: 8784755
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10884524001555
• UDI-Public: (01)10884524001555
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: SE3690
• Device Catalogue Number: SE3690
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1