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

Model Number SE3695

Device Problems Overheating of Device (1437); Smoking (1585); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273); Intermittent Energy Output (4025)

Patient Problem No Code Available (3191)

Event Date 09/11/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, intra-operatively, the device overheated while the engine was moving.After, a loud noise was heard, the device went out and there was a lot of smoke came out of the device.An electric fire extinguisher was used on the machine.The patient inhaled the smoke.No further information available.

Manufacturer Narrative

Evaluation summary: one device was received as a service request and a visual inspection and functional test were performed.The returned device did not meet specification as received.According to the reporter, intra-operatively, the device overheated while the engine was moving.After, a loud noise was heard, the device went out and there was a lot of smoke came out of the device.The reported condition was confirmed.Inspection of the device resulted in finding the engine blades had become loose.The investigation found the most probable cause of the reported event to be wear and tear.The motor was replaced to address the issue.The system passed all required tests.The filter check, the flow control, the footswitch operation, the interlink function, the turbo mode, and the low frequency electrical safety test passed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RAPIDVAC
• Type of Device: APPARATUS, EXHAUST, SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow drive; boulder CO 80301 3299
• MDR Report Key: 9154599
• MDR Text Key: 161164422
• Report Number: 1717344-2019-01256
• Device Sequence Number: 1
• Product Code: FYD
• UDI-Device Identifier: 10884524001753
• UDI-Public: 10884524001753
• Combination Product (y/n): N
• PMA/PMN Number: K980915
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SE3695
• Device Catalogue Number: SE3695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Date Manufacturer Received: 11/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1