MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC HARMONIC ACE 36CM; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HAR36

Device Problems Premature Activation (1484); Temperature Problem (3022)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 05/02/2023

Event Type  malfunction  

Event Description

Harmonic ace laparoscopic shears (ref har36, lot# x96h82).Circulator had plugged in handpiece cord into console and surgical tech had just finished attaching cord to handpiece and immediately tip was hot enough to burn through staff member's gown to her skin, prior to even testing it without activating the handpiece.Left a small red mark, no open skin, and no treatment required.Handpiece removed from field, replaced with new handpiece which was carefully tested and worked fine.

• Brand Name: HARMONIC ACE 36CM
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC; 475 calle c; guaynabo PR 00969
• MDR Report Key: 16960637
• MDR Text Key: 315548551
• Report Number: 16960637
• 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: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HAR36
• Device Catalogue Number: HAR36
• Device Lot Number: X96H82
• 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: 05/04/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1