MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SHEARS; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HAR9F

Device Problems Defective Device (2588); Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 12/23/2021

Event Type  Injury  

Event Description

Harmonic shears tips did not heat up for procedure.The wrong part of the shears and handle became hot and burned patient's right cheek.The test of the device prior to use was performed and it registered as passed the test.Fda safety report id# (b)(4).

• Brand Name: HARMONIC SHEARS
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; guaynabo PR 00969
• MDR Report Key: 13236804
• MDR Text Key: 283783167
• Report Number: MW5106590
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HAR9F
• Device Lot Number: U40F11
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American