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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: the harmonic handpiece would not connect with the power source, and while doing the mandatory testing to start it up, the surgical tech felt an unusual clicking.We chose to replace it with a new one and everything worked correctly with the new handpiece.

• Brand Name: HARMONIC FOCUS
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 5300 region court; lakeland FL 33815
• MDR Report Key: 10493593
• Report Number: 10493593
• Device Sequence Number: 16944766
• Product Code: NLQ
• UDI-Device Identifier: 07613327348248
• UDI-Public: (01)07613327348248
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2020
• Report Date (Section F): 08/21/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: HAR9F
• Device Lot Number: 11619361
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 66
• Date Report Sent to FDA: 08/21/2020