MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS HARMONIC ACE SHEARS, 5MM X 36CM; HARMONIC SCALPEL

Model Number HAR36

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 08/10/2016

Event Type  malfunction  

Event Description

Stryker sustainability, ethicon endo-surgery, harmonic ace shears generator beeped, and a message to "replace handpiece" was displayed approximately 7-10 minutes into procedure.The existing handpiece was exchanged for another "like" handpiece with an identical lot number, which functioned without incident for the remainder of the procedure.Reason for use: laparoscopic bilateral salpingectomy.Is the product compounded: no.Is the product over the counter: no.

• Brand Name: HARMONIC ACE SHEARS, 5MM X 36CM
• Type of Device: HARMONIC SCALPEL
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; lakeland FL 33815
• MDR Report Key: 5878260
• MDR Text Key: 52316369
• Report Number: MW5064087
• 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: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2017
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: 4604716
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR