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

Model Number ETHER420

Device Problems Failure to Cycle (1142); Material Deformation (2976)

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

Event Date 10/03/2014

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic hepatectomy when trying to load the device, clips failed to load at all, loaded only "halfway" or fired two at a time on top of each other.It was also reported that clips came out crossed.It was uncertain whether any clips were applied correctly prior to the issues.Some clips were fired outside the body, and those clips also had one or more of the problems.There was no torquing of the device.Another device was used to complete the procedure.There was a delay caused.There was no patient injury.

Manufacturer Narrative

The device was returned to the manufacturer for device evaluation.A supplemental report will be sent when device evaluation is complete.

• Brand Name: NA
• 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: 4280414
• MDR Text Key: 5298049
• Report Number: 2134070-2014-00188
• 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: 10/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: ETHER420
• Device Catalogue Number: ER420
• Device Lot Number: 1747087
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2014
• 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