MAUDE Adverse Event Report: STERILMED, INC.

Model Number ETHACE36E

Device Problems Thermal Decomposition of Device (1071); Device Inoperable (1663)

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

Event Date 01/01/2013

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic partial gastrectomy the tip of the device burned, then the device stopped functioning.Another device was used to complete the procedure.There was a two minute delay, and no patient injury.This report is being filed for the findings upon device investigation.

Manufacturer Narrative

Final device investigation found that the device was returned with the tissue pad melted and split, and the tip of the pad broken off and not returned with the device.Upon evaluation, the device passed all electrical testing, including a self-test and button tests.The device history record was reviewed, and no discrepancies were noted.

• Brand Name: NA
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 3747909
• MDR Text Key: 4552362
• Report Number: 2134070-2014-00020
• 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: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2014
• Device Model Number: ETHACE36E
• Device Catalogue Number: ACE36E
• Device Lot Number: 1709284
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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