MAUDE Adverse Event Report: ETHICON J&J HARMONIC SCALPEL; EES GENERATOR

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 09/15/2016

Event Type  Other  

Event Description

Harmonic scalpel used and placed on drape.Scrub personnel asked if instrument performing appropriately as had burn mark on drape where device was placed.Upon inspection of device was noted to have a plastic portion missing.Device was removed from the field and replaced.Damaged device was retained per protocol.

• Brand Name: J&J HARMONIC SCALPEL
• Type of Device: EES GENERATOR
• Manufacturer (Section D): ETHICON; route 22 ; west somerville NJ 08876
• MDR Report Key: 6215315
• MDR Text Key: 63727037
• Report Number: MW5066980
• Device Sequence Number: 1
• Product Code: HGI
• 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: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR