MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS FOCUS 9CM PLUS ADAPTIVE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR9F

Device Problems Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)

Patient Problems Scar Tissue (2060); Burn, Thermal (2530); Full thickness (Third Degree) Burn (2696); No Code Available (3191)

Event Date 01/07/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # p9363w.Investigation summary: the device was returned with no apparent damage.  the device was connected to a test handpiece and generator and it did activate.During functional testing, the device was activated for about 1 minute with no abnormal heat observed.  the instrument was disassembled and it was found to have thermal damage at the shrouds.Heat was generated at this area resulting in the melting of the shrouds.  this damage could have resulted from not torquing the instrument properly to the hand piece; resulting in excessive heat generation at the shrouds the batch history record was reviewed and no defects, nc¿s or protocols related to the complaint, were found during the manufacturing process.Additional information: what is the surgeon experience with this device? she uses on a weekly basis.She is very comfortable with the device and knows to takes steps to cool down the device.She expressed that it was the first time she felt the device arm get heated.The tech noticed that when the surgeon handed the device off during the procedure, they could feel the heat of the device through their gloves.How long had the device been used? during procedure.What heat management technique were utilized during surgical procedure? wet gauze.Where is the burn in relation to the incision? on the neck.When was the burn noticed? during procedure.Will the patient need any follow-up? pt has been seen as a follow up- will need cosmetic procedure around the area it was burnt.What is the current patient condition? scar looks sub optimal.Pt is ok, scar will need a cosmetic revision.

Event Description

It was reported that during a thyroidectomy the blade of the device got very hot and when the surgeon laid the device on the patient's neck the patient was burned.The device was noted to be hotter than normal tip to tip.Heat came from the entire device.The active blade piece was hottest.The burn came from the metal piece laying on the patient¿s neck.The severity of the burn was third degree.The tissue of the burn had to be excised.The procedure was completed with an alternate like device.

• Brand Name: HS FOCUS 9CM PLUS ADAPTIVE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: milton garrett ; 475 calle c; guaynabo 00969 ; 5133378865
• MDR Report Key: 7232681
• MDR Text Key: 98734816
• Report Number: 3005075853-2018-07679
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20705036014666
• UDI-Public: 20705036014666
• Combination Product (y/n): N
• PMA/PMN Number: K132612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: HAR9F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention