MAUDE Adverse Event Report: ETHICON ENDOSURGERY, INC. ETHICON; HARMONIC SCALPEL

Model Number HARHD36

Device Problems Detachment Of Device Component (1104); Sparking (2595)

Patient Problem No Information (3190)

Event Date 05/23/2017

Event Type  Injury  

Event Description

During a liver resection white rubber piece of the jaws came off and started sparks.

• Brand Name: ETHICON
• Type of Device: HARMONIC SCALPEL
• Manufacturer (Section D): ETHICON ENDOSURGERY, INC. ; cincinnati OH 45242
• MDR Report Key: 7101027
• MDR Text Key: 94374422
• Report Number: MW5073851
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARHD36
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• 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