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

Model Number HAR9F

Device Problem Failure to Sense (1559)

Patient Problem No Information (3190)

Event Date 08/15/2018

Event Type  malfunction  

Event Description

Prior to use on patient the harmonic shear was tested.The machine would not recognize the harmonic device.

• Brand Name: HARMONIC FOCUS SHEARS
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS, INC.; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 7841508
• MDR Text Key: 119039384
• Report Number: 7841508
• 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: 08/20/2018

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: No Information
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9F
• Device Lot Number: 8786701
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2018
• Date Report to Manufacturer: 09/04/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 14235 DA