MAUDE Adverse Event Report: ETHICON HARMONIC SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HD100I

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2017

Event Type  malfunction  

Event Description

Pt underwent laparoscopic hysterectomy.During the procedure, the harmonic shears that the surgeon was using malfunctioned.There was no injury to the pt.The procedure was completed.The shears were immediately removed from service and were sent back to the company.This situation is voluntarily reported to the fda.

• Brand Name: HARMONIC SHEAR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON
• MDR Report Key: 6409802
• MDR Text Key: 70268327
• Report Number: MW5068479
• Device Sequence Number: 1
• Product Code: NAY
• 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: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HD100I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2017
• 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): Other
• Patient Age: 31 YR
• Patient Weight: 77