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

Catalog Number HAR9F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Paralysis (1997); Respiratory Distress (2045); No Code Available (3191)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.What specific procedure was har9f used on? what is the surgeon¿s experience with this surgical procedure? what is surgeon¿s experience with this device? in what area was the device used during the procedure? what was the cause of the respiratory problem? what is the correlation between the reported event and device? what heat management techniques were used during the procedure? has the patient recovered from the vocal cord injury? were both cords injured? is the surgeon alleging there was a deficiency with the device? to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that during and unknown procedure, the patient had respiratory difficulties and damage to the vocal cords with significant lowering of the voice after the surgical procedure.The generator did not display any error messages, the device passed the pre-run test, and the device did not stop working during the initial procedure.

Manufacturer Narrative

(b)(4).Additional information received: after thyroidectomy, vocal cord paralysis occurred on the same day using the same apparatus.Dyspnea immediately after waking up.Laryngoscopy shows paresis and intense edema of the vocal cords with reduced respiratory space and aphonia.The surgeon does not use and has not used ultrasound during the dissection of the recurrent nerve.During the intervention, the appliance has raised an alarm as from excessive pressure on the handpiece.

• 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
• MDR Report Key: 8352234
• MDR Text Key: 136584398
• Report Number: 3005075853-2019-16707
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: HAR9F
• Device Lot Number: R4065M
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2019
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Other