MAUDE Adverse Event Report: STERILMED, INC.; ELECTROSURGICAL, CUTTING/COAGULATION

Model Number COVLF1537

Device Problem Failure to Power Up (1476)

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

Event Date 07/01/2014

Event Type  malfunction  

Event Description

It was reported that the device would not work when plugged in, and that the device was not used on a pt.Another device was used to complete the procedure.There was no pt injury.This report is being filed for the findings upon investigation.Add'l info was requested, but no add'l info was provided.A supplemental report will be sent if add'l info is received.

Manufacturer Narrative

Final device investigation found that the device was returned with its jaws and handle latched and locked, and the switch at the back of the handle severely damaged with the switch cover broken off.Upon eval, the jaws of the device could not be opened.It was not reported whether the jaws were on the pt when they locked.The jaws appeared to be in alignment, and the blade was fully retracted and could actuate and release freely.Electrical tested could not be performed due to the condition of the returned device.The device history record was reviewed, and no discrepancies were noted.

• Brand Name: NA
• Type of Device: ELECTROSURGICAL, CUTTING/COAGULATION
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4239721
• MDR Text Key: 5064325
• Report Number: 2134070-2014-00184
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123096
• 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: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Model Number: COVLF1537
• Device Catalogue Number: LF1537
• Device Lot Number: 1741234
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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