MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS LAKELAND ETHICON HARMONIC FOCUS; INSTRUMENT, ULTRASONIC SURGICAL

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 06/16/2015

Event Type  Death  

Event Description

Patient had a near total thyroidectomy with recurrent laryngeal monitoring.At the end of the procedure, hemostasis was achieved using a combination of surgicel and electrocautery.There were no signs of bleeding.Procedure ended around 0835.His initial recovery was going smoothly until approximately 0400 the following morning when he rapidly developed a hematoma in the neck and difficulty breathing.He returned to the or where bleeding was identified from the right superior thyroid artery.It appeared that all bleeding vessels were previously ligated with the harmonic focus handpiece.

• Brand Name: ETHICON HARMONIC FOCUS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS LAKELAND; 5300 region court; lakeland FL 33815
• MDR Report Key: 4934837
• MDR Text Key: 6041200
• Report Number: 4934837
• Device Sequence Number: 1
• Product Code: NLQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Weight: 67