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

Catalog Number HAR9F

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Burn, Thermal (2530); Full thickness (Third Degree) Burn (2696)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.The lot history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

Event Description

It was reported that while the surgeon was completing an axillary clearance procedure with the registrar, while utilizing the focus+ device when needed, the registrar rested the device on the patients arm at points during the procedure and there was a third degree burn to the patient.The burn was treated with a dressing and they are unsure if there will be any long term effects from the burn.

Manufacturer Narrative

(b)(4).Additional information was requested, and the following was received: jjm rep advised that she did follow up with surgeon and all he advised is that post-op was as per usual, the thermal burn is minor and only put on a dressing to wound.No other information provided.From the surgeon's description of the event, it was not long after activation that the device then rested on the patient.

• 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: 8084456
• MDR Text Key: 127576768
• Report Number: 3005075853-2018-14439
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036014669
• UDI-Public: 10705036014669
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: HAR9F
• Device Lot Number: P4T15F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Other