MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS STRYKER HARMONIC FOCUS; SCALPEL, ULTRASONIC REPROCESSED

Lot Number 10152389

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2019

Event Type  malfunction  

Event Description

During a total thyroidectomy procedure, a harmonic focus handpiece began to spark.The device was removed from the sterile field and replaced.No harm was noted to the pt.Fda safety report id# (b)(4).

• Brand Name: STRYKER HARMONIC FOCUS
• Type of Device: SCALPEL, ULTRASONIC REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS
• MDR Report Key: 9244526
• MDR Text Key: 164109004
• Report Number: MW5090669
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2022
• Device Lot Number: 10152389
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1