MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS HARMONIC ACE SHEARS; HARMONIC SCALPEL

Model Number HAR36

Device Problems Device Displays Incorrect Message (2591); Naturally Worn (2988); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 10/23/2017

Event Type  malfunction  

Event Description

While using a stryker sustainability solutions harmonic ace shears the generator kept reading "tighten assembly".It was tightened twice and the handpiece then made a loud "screeching" sound when cutting tissue.A new "like" device with the same lot # was subsequently opened and utilized.During the use of this 2nd instrument it was noted that the insulation of this device had worn from the tip.(two "like" devices with same lot # with identified issues).

• Brand Name: HARMONIC ACE SHEARS
• Type of Device: HARMONIC SCALPEL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85283
• MDR Report Key: 6975793
• MDR Text Key: 90308950
• Report Number: MW5072936
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/24/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2018
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: 7071568
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Age: 54 YR