MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, INC HARMONIC FOCUS BLUE HAND PIECE; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HAR9F

Device Problems Device Displays Incorrect Message (2591); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/12/2020

Event Type  malfunction  

Event Description

When hooking the hand piece up to the console, it would not work.Error on console showed "hand piece failed".

• Brand Name: HARMONIC FOCUS BLUE HAND PIECE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, INC; 4545 creek road; cincinnati OH 45242
• MDR Report Key: 10060881
• MDR Text Key: 191130102
• Report Number: 10060881
• Device Sequence Number: 1
• Product Code: LFL
• 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: 05/13/2020

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
• Device Operator: No Information
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9F
• 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: 05/13/2020
• Date Report to Manufacturer: 05/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1