MAUDE Adverse Event Report: STERILMED, INC.; CLIP APPLIER

Model Number ETHMCL20

Device Problems Mechanical Problem (1384); Misfire (2532)

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

Event Date 08/05/2014

Event Type  malfunction  

Event Description

It was reported that the device was not forming a proper clip and a second device jammed.It was later reported that the device would not produce a clip.The handle would then be stuck and not open, this happened several times for both the first and second device.There was no patient injury.The report for this device is being filed for the findings upon investigation.Additional information was requested, but no additional information was available.

Manufacturer Narrative

Final device investigation found that the device was returned with the clip retainer out of position.Upon evaluation, it was found that the device did not have sufficient spring compression.The remaining six clips were then fired from the device.Each clip was ejected from the device unformed as the clips were not guided into the jaws for proper placement.After all of the clips were fired, the locking mechanism did not engage.The device history record was reviewed, and no discrepancies were noted.As each device is visually inspected and functionally tested prior to release, no conclusion could be made as to what may have caused the reported event.

• Brand Name: NA
• Type of Device: CLIP APPLIER
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 4068375
• MDR Text Key: 4813230
• Report Number: 2134070-2014-00158
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2015
• Device Model Number: ETHMCL20
• Device Catalogue Number: MCL20
• Device Lot Number: 1760232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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