MAUDE Adverse Event Report: STRYKER SUSTAINABILITY SOLUTIONS HARMONIC FOCUS SHEARS; SCALPEL, ULTRASONIC, REPROCESSED

Model Number	N/A
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The pt was undergoing a surgical procedure, when the surgeon was using the harmonic focus shears and adaptive tissue technology 9cm.The instrument stopped working in the middle of the procedure.It was removed from the sterile field and replaced so the surgeon could continue.No harm noted to the pt.Fda safety report id# (b)(4).

• Brand Name: HARMONIC FOCUS SHEARS
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; tempe AZ 85283
• MDR Report Key: 9244404
• Report Number: MW5090661
• Device Sequence Number: 2030981
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: (01)07613327348248
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2022
• Device Model Number: N/A
• Device Catalogue Number: HAR9F
• Device Lot Number: 10603499
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR