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

Catalog Number HAR9F

Device Problems Device Displays Incorrect Message (2591); Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 04/12/2019

Event Type  malfunction  

Event Description

Prior to use on patient, the harmonic device was plugged in and tested and continued to get "error" reading.The device would not open.A new device was obtained and the case continued without incident.

• Brand Name: HARMONIC FOCUS SHEARS
• Type of Device: ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STRYKER SUSTAINABILITY SOLUTIONS; 1810 w. drake dr.; tempe AZ 85283
• MDR Report Key: 8645216
• MDR Text Key: 146211791
• Report Number: 8645216
• 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: 05/13/2019

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 Catalogue Number: HAR9F
• Device Lot Number: 9270763
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2019
• Date Report to Manufacturer: 05/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 29200 DA