MAUDE Adverse Event Report: STERLIMED, INC.

Model Number COVLF1537

Device Problem Failure to Auto Stop (2938)

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

Event Type  malfunction  

Event Description

It was reported that the device would not power off.Another device was used to complete the case.There was no pt injury and no effect on the procedure.Additional information was requested, not no additional information was available.

Manufacturer Narrative

Final device investigation found that the device was returned with jaws and handle closed and locked, and the cord clipped and the connector used to plug into the generator removed.Upon evaluation, the handle was difficult to latch and unlatch, which has been seen when the handle is locked for a length of time.The handle could be opened by putting pressure in the closing handle and twisting it slightly to the left.The blade operated as intended.Electrical testing could not be performed due to the condition of the device.The device history record was reviewed, and no discrepancies were noted.

• Brand Name: NA
• Manufacturer (Section D): STERLIMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 3727549
• MDR Text Key: 16012073
• Report Number: 2134070-2014-00048
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2014
• Device Model Number: COVLF1537
• Device Catalogue Number: LF1537
• Device Lot Number: 1634104
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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