MAUDE Adverse Event Report: STRYKER SUSTAINIBILITY SOLUTIONS HARMONIC ACE SHEARS 5 MM / 36 CM; HARMONIC SCALPEL

Model Number HAR36

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

Two stryker sustainability solutions harmonic ace shears with the same lot number were not functioning properly and were replaced with a third device with a different lot number that was utilized to complete the surgical procedure.Device #1: generator displayed "reactive," handpiece was retested numerous times but would not pass test.Device #2: the jaws of the handpiece would not consistently close, handpiece was readjusted multiple times with the same issue still being noted.Used for laparoscopic supracervical hysterectomy.Event reappeared after reintroduction.

• Brand Name: HARMONIC ACE SHEARS 5 MM / 36 CM
• Type of Device: HARMONIC SCALPEL
• Manufacturer (Section D): STRYKER SUSTAINIBILITY SOLUTIONS; lakeland FL
• MDR Report Key: 4438718
• MDR Text Key: 5313411
• Report Number: MW5040280
• Device Sequence Number: 1
• Product Code: NLQ
• 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: 01/13/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: 3332951
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 62 YR