MAUDE Adverse Event Report: STERILMED, INC.; ULTRASONIC SCALPEL

Model Number ETHACE36E

Device Problem Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported that the device was defective, noticed before the procedure, never touched the patient.There was no patient injury.Additional information was requested, but no additional information was available.This report is being filed for the findings upon investigation.

Manufacturer Narrative

Final device investigation found that the device was returned with the blade blackened and the tissue pad severely melted and blackened.The right tip of the pad was detached and not returned with the device, and the remaining portion was curled upwards off the jaw.Upon evaluation, the device passed all mechanical and electrical testing.The clamp arm was able to fully open and close, the trigger operated as designed, the buttons operated as intended and no error codes were displayed on the generators when the device was connected.The device history record was reviewed, and no discrepancies were noted.A melted and broken tissue pad is consistent with the device being run with the jaw closed and insufficient tissue being between the blade and the jaw.

• Brand Name: NA
• Type of Device: ULTRASONIC SCALPEL
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4071199
• MDR Text Key: 4900201
• Report Number: 2134070-2014-00160
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050343
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2014
• Device Model Number: ETHACE36E
• Device Catalogue Number: ACE36E
• Device Lot Number: 1704166
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1