MAUDE Adverse Event Report: ETHICON ENDO-SURGERY HARMONIC ACE

Device Problems Other (for use when an appropriate device code cannot be identified) (2203); Insufficient Information (3190)

Patient Problem Burn(s) (1757)

Event Date 11/03/2015

Event Type  Injury  

Event Description

(b)(6) taken to operating room for procedure.Harmonic ace was used during procedure and patient had a small area of burn on the skin laterally above the incision.Plastic surgery was consulted, determined the patient had second degree burn and recommended bacitracin ointment be applied.

• Brand Name: HARMONIC ACE
• Type of Device: HARMONIC ACE
• Manufacturer (Section D): ETHICON ENDO-SURGERY; 4545 creek rd.; cincinnati OH 45242
• MDR Report Key: 5235486
• MDR Text Key: 31677955
• Report Number: 5235486
• Device Sequence Number: 1
• Product Code: LFL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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: 11/06/2015
• Distributor Facility Aware Date: 11/03/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2015
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR