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 Date 11/04/2016

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 during a case.No patient injury or consequences were reported.Additional information request received in a photo of the malformed clip in a tear drop shape with double clips formed together.

Manufacturer Narrative

The clip applier was returned with only a single clip remaining which was present in the jaws.The device was fired and the single clip that was produced before the locking mechanism engaged displayed the proper pinch and alignment.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: 6132879
• MDR Text Key: 61084679
• Report Number: 2134070-2016-00087
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• 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: 12/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• 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