MAUDE Adverse Event Report: STERILMED, INC.

Model Number ETHER320

Device Problem Mechanical Problem (1384)

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

Event Type  malfunction  

Event Description

It was reported that the device was not working during the procedure.It misfired and did not fire straight.Another device was used.The intent of the procedure was not altered.No injury was reported.This report is being filed for the findings upon device investigation.Additional information was requested, but no additional information was provided.

Manufacturer Narrative

Final device investigation found that the device returned was an ether420 and was in good visual condition.Upon evaluation, the remaining 11 usable clips were fired.The first three clips had proper pinch but not proper alignment, they were scissored.The fourth clip came out sideways and unformed.The remaining seven clips did not load properly into the jaws and came out of the device sideways and unformed.After the last clip was fired, the locking mechanism engaged as intended.The device had been sent out with 14 clips.The lot number was not provided, so the device history record could not be reviewed.As each device is test fired prior to release, no conclusion could be made as to what may have caused the reported event.

• 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: 3721178
• MDR Text Key: 4268315
• Report Number: 2134070-2014-00055
• Device Sequence Number: 1
• Product Code: NMJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033579
• 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: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ETHER320
• Device Catalogue Number: ER320
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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