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

Model Number ETHER320

Device Problems Positioning Failure (1158); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2016

Event Type  Injury  

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 reviewed and no discrepancies were found.

Event Description

It was reported that during a laparoscopic colectomy, the device misfired and subsequently jammed the clip sideways, the end of the clip punctured the bile duct and was immediately repaired.No further patient injury or consequence was reported.

Manufacturer Narrative

The device was returned to the manufacturer and was subjected to full functional testing.The device was fired until all clips were spent the device produced 5 clips of appropriate pinch and alignment.No defect was detected.Unable to confirm account complaint.

• 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 ; 7635888348
• MDR Report Key: 5625466
• MDR Text Key: 44243336
• Report Number: 2134070-2016-00025
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/30/2016
• Device Model Number: ETHER320
• Device Catalogue Number: ETHER320
• Device Lot Number: 1905374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR
• Patient Weight: 138