MAUDE Adverse Event Report: STERILMED, INC.

Model Number ETHMCM30

Device Problem Failure to Cycle (1142)

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

Event Date 05/17/2014

Event Type  malfunction  

Event Description

It was reported that the device would not lead a clip properly.The clips did not load into the jaws and the tips would not open.No clips were successfully loaded and fired.There was no unexpected resistance or noise heard.Another device was used to complete the procedure.There was no patient injury.This report is being filed for the findings upon investigation.

Manufacturer Narrative

Final device investigation found that the device was returned with a clip stuck in the jaw, and a crack on the base of the device at the seam.Upon evaluation, the clip that was stuck in the jaw was removed, and the remaining clips wer fired from the device.The removed clip was partially pinched.Clips 2-7 did not load properly into the device jaw and were removed.Clips 2, 4 and 5 were only partially pinched.Clips 8, 0 and 10 loaded properly into the jaws and had proper pinch.Clip 11 did not load properly into the jaw and was unformed.Clip 12 loaded into the jaw, but did not fire and remained unformed in the jaw.The handle of the device did not lock and could still be actuated, but the jaw did not respond to the handle and remained fixed in the open position.The device had been sent out with 13 clips and was returned with 12 clips.No lot number was provided, so the device history record could not be reviewed.

• 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: 4162670
• MDR Text Key: 4785775
• Report Number: 2134070-2014-00137
• 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: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ETHMCM30
• Device Catalogue Number: MCM30
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2014
• 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