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

Model Number HAR36

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/26/2017

Event Type  malfunction  

Event Description

When attempting to utilize a new stryker sustainability solutions harmonic ace shears, an orange screen appeared on the generator stating to replace the instrument.10 uses.

• Brand Name: HARMONIC ACE SHEARS
• Type of Device: HARMONIC SCALPEL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85283
• MDR Report Key: 6986706
• MDR Text Key: 90678491
• Report Number: MW5073025
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2018
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: 7097807
• 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: 48 YR