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

Model Number HAR9F

Device Problem Device Sensing Problem (2917)

Patient Problem No Information (3190)

Event Date 09/04/2018

Event Type  malfunction  

Event Description

The harmonic device was not recognized when plugged in.Another device obtained with similar outcome.A bipolar cautery was used instead without further incident.

• Brand Name: HARMONIC FOCUS
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 7955555
• MDR Text Key: 123374210
• Report Number: 7955555
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HAR9F
• Device Lot Number: 8786701 AND 8404301
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2018
• Date Report to Manufacturer: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA