MAUDE Adverse Event Report: STERILMED, INC

Model Number VALLS1037

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, but no additional information was available.

Manufacturer Narrative

Final device investigation found that the device was returned in good visual condition.Upon evaluation the device jaws, trigger, switches, blade and levers operated as intended.The device was electrically tested.During a switch test, a multimeter sounded constantly whether the switch was depressed or not.When connected to a generator error codes "regrasp tissue/clean electrodes" and "endpoint not reached/try again" were displayed.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 ave; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 3727551
• MDR Text Key: 18367704
• Report Number: 2134070-2014-00047
• Device Sequence Number: 1
• Product Code: NUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012598
• 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: 08/01/2014
• Device Model Number: VALLS1037
• Device Catalogue Number: LS1037
• Device Lot Number: 1691435
• 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: 08/01/2013
• 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