MAUDE Adverse Event Report: HARMONIC FOCUS SHEARS; INSTRUMENT, ULTRASONIC SURGICAL

Device Problem Material Fragmentation (1261)

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

Event Date 09/19/2019

Event Type  malfunction  

Event Description

During thyroidectomy procedure, the surgeon attempted to use the harmonic focus shear, when the textured surface of the shear head vaporized into a fine dust.The incision was copiously irrigated, and another shear package was opened and handed to the surgeon, but the textured surface on this one again crumbled into dust.The incision was again irrigated.Both of these devices were 3rd party reprocessed instruments.(b)(4).

• Brand Name: HARMONIC FOCUS SHEARS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• MDR Report Key: 9146811
• MDR Text Key: 161368830
• Report Number: MW5090174
• Device Sequence Number: 2
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/30/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR