MAUDE Adverse Event Report: STERILMED, INC.; CLIP, IMPLANTABLE, REPROCESSED

Model Number ETHER320

Device Problems Mechanical Problem (1384); Material Deformation (2976)

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

Event Date 09/08/2014

Event Type  malfunction  

Event Description

It was reported that the first clip came out crimped before event being placed on the vessel.Then when trying to use it again, it kept spitting out an extra clip.There was no patient injury.It was later reported that the procedure was a laparoscopic cholecystectomy.The "crimped" clip was crossed.The extra clips coming out of the device were not unformed.The issue occurred when firing over the cystic duct.There was no resistance felt when firing the device.The device was tried a second time and the clips were crossed.The device was replaced with a device from another manufacturer.The procedure was prolonged, but no time was provided.

Manufacturer Narrative

The device has not been received at the manufacturer's facility as of the date of this report.A supplemental report will be filed after investigation if the device is received.

• Type of Device: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4152556
• MDR Text Key: 15328373
• Report Number: 2134070-2014-00176
• 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: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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