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

Model Number HAR9F

Device Problems Failure to Cut (2587); Output Problem (3005)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 10/15/2021

Event Type  malfunction  

Event Description

The harmonic device was not working.It wouldn't test correctly then when it did it would not cut the vessels and tore a vein that caused more bleeding than usual.The device also buzzed when we were checking it with biomed when the jaws were open.There was also a previous incident where the harmonic was not acting as it should.Because of a malfunction, a provider ended up injuring the thoracodorsal vein, and it had to be ligated.Bio med was contacted about the issue, and a combination of two separate cords and two harmonic generators were tested, but none worked properly.Manufacturer response for instrument, ultrasonic surgical, harmonic focus (per site reporter).

• 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: 12770161
• MDR Text Key: 280458199
• Report Number: 12770161
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/03/2021,10/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: HAR9F
• Device Catalogue Number: HAR9F
• Device Lot Number: 285A93
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24820 DA
• Patient Sex: Female