MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY (SALIENT) PLASMABLADE 3.0PLUS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PS210-030P
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a manufacture representative (rep) regarding a generator and a handpiece.It was reported that when the doctor used the handpiece for about 30 minutes, he found that the plastic film on the tip of the handpiece had melted, so the doctor replaced a handpiece to complete the operation.There was no reported impact to patient outcome.
Additional Manufacturer Narrative
H3: analysis summary: complaint confirmed: upon receiving the device, the clear heat shrink on the neck of the blade was torn from the top to where the collet but was still attached to the disposable.The clear heatshrink component was observed and confirmed the heat shrink was assembled and heated properly defined in product specifications by the indentions on the sides of the heatshrink that shrinks on the shaft of the blade and below the shoulders of the blade.No tears at the top of the heat shrink which insists the clear heat shrink was not assembled over the shoulder.There were no indentions indicating the component was assembled higher than what is instructed in the mentioned work instructions which confirms there was no manufacturing errors during manufacturing.The device was still tested for continuity and connected to the complaint lab generator and tested for its functionality and cleaned the device as recommended in the ifu and the product specifications defined.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 3.0PLUS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY (SALIENT); 180 international drive; portsmouth NH 03801
• MDR Report Key: 11164468
• Report Number: 1226420-2021-00013
• Device Sequence Number: 14382461
• Product Code: GEI
• UDI-Device Identifier: 00643169617131
• UDI-Public: 00643169617131
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K102709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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 Expiration Date: 01/02/2023
• Device Model Number: PS210-030P
• Device Catalogue Number: PS210-030P
• Device Lot Number: 0219132171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2020
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1