MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC HARMONIC FOCUS; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HAR9F

Device Problems Loose or Intermittent Connection (1371); Noise, Audible (3273)

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

Event Date 06/23/2020

Event Type  malfunction  

Event Description

Harmonic focus would not tighten, and machine was making noises.Manufacturer response for harmonic focus, harmonic focus (per site reporter), none.

• Brand Name: HARMONIC FOCUS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 10447718
• MDR Text Key: 204192242
• Report Number: 10447718
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2020
• 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: 11644555
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2020
• Date Report to Manufacturer: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA