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

Model Number SE3690

Device Problems Defective Device (2588); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

Event Description

In (b)(6) 2022, there were a total of five smoke evacuation systems that were intermittently not working during surgical procedures.All connections were checked and power cycled/restarted; however, systems continued to not always engage during the surgical procedure.Early february, three smoke evacuation units were reported to medtronic with intermittent operation issues.Biomed reported to medtronic that a fourth smoke evacuation system is having intermittent operation issues.Biomed reported a fifth unit to medtronic with intermittent operation issues.The smoke evacuators were purchased in 2020 and were all past their one year warranty.We replaced the five smoke evacuators with new ones.Medtronic has not given any follow up of cause of intermittent operation.In (b)(6), we have an additional three smoke evacuation systems that will need to be replaced because of the "intermittent operation" issue.These units were all purchased in 2020 with recent pms.Event: smoke evacuation was intermittently working during a surgical procedure.Team checked all connections and power cycled/restarting system.System continued to not always engage when cautery used.Biomedical engineering contacted medtronic/covidien representative and this device will be replaced.Event: smoke evacuation intermittently not working during a case.All connections were checked and power cycled and still continued to not always engage when cautery in use.Pulled from service and biomedical engineering ran the unit continuously for three hours and no problem was found.This pump will be monitored for issues and is not being replaced at this time.Event: smoke evacuator intermittently not working while cautery is engaged.Or team attempted a power cycle and double-checked al connections, unit still malfunctioning.Evacuator removed from service and biomedical engineering inspected and tested the evacuator and the issue of intermittent on/off cycling was verified by testing.Biomedical engineering contacted medtronic/covidien representative and this device will be replaced.Event: smoke evacuator was intermittently not working while cautery engaged.All connections were checked and power cycled and still continued to not always engage when cautery in use.Biomedical engineering contacted medtronic/covidien representative and this device will be replaced.No patient injury resulted in any of the above listed events.

• Brand Name: RAPIDVAC
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13937860
• MDR Text Key: 288099597
• Report Number: 13937860
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10884524001555
• UDI-Public: 10884524001555
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/28/2022,03/22/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/28/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/29/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1