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

Model Number ETHER320

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to the manufacturer at the time of this report.A supplemental form will be sent once the evaluation is completed if the device is returned.The device history report was not able to be reviewed as no lot number was given.

Event Description

It was reported that the device misfired by twisting staples and scissoring.No patient harm was reported.Additional information was requested, but additional information was not available.

Manufacturer Narrative

The complaint device was function tested and fired until all remaining clips were spent.The device displayed no defect and every clip that was fired displayed the proper alignment and pinch.No defect was found with the performance of the device.Based on this evidence the account's complaint could not be confirmed.

• Type of Device: CLIP, IMPLANTABLE, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove MN
• Manufacturer Contact: jason anderson ; 5010 cheshire parkway; suite 2; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 6076652
• MDR Text Key: 59078801
• Report Number: 2134070-2016-00080
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ETHER320
• Device Catalogue Number: ETHER320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2016
• 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