MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PLASMABLADE X; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number PS210-030S-LIGHT

Device Problems Failure to Shut Off (2939); Noise, Audible (3273)

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

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturing representative (rep) regarding a generator.It was reported that the site had a couple handpieces that had an issue where the tone and blade continued after the surgeon had stopped pressing the button.It was clarified that the handpieces were lighted and continued to produce power and noise after the surgeon had removed their finger from the button.There generator was still in use and there was no impact to patient outcome.

Manufacturer Narrative

H3: analysis summary: complaint not confirmed: the device was decontaminated prior to the analysis of this complaint.The device was tested for its functionality and continuity and passed.The device was also connected to the complaint lab aex generator and continued the functional tests.The device had a glow on both the cut and coag modes and was depressed fifty (50) times for both modes combined as defined in procedure.The cut and coag buttons had no failures when depressed and during functional tests.No failures were found during analysis.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: PLASMABLADE X
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 10906972
• MDR Text Key: 218679329
• Report Number: 1226420-2020-00152
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00763000279189
• UDI-Public: 00763000279189
• Combination Product (y/n): N
• PMA/PMN Number: K093695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: PS210-030S-LIGHT
• Device Catalogue Number: PS210-030S-LIGHT
• Device Lot Number: 2005069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1