MAUDE Adverse Event Report: STERILMED, INC.; LAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Model Number ETH2B5LT

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2016

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 reviewed and no discrepancies were found.

Event Description

It was reported that when used during a laparoscopic appendectomy, it was noticed that the device had a piece of something black in it.The device was immediately removed from the patient and a new device was used.It was reported that there was no patient injury or consequences associated with this.

Manufacturer Narrative

The device was returned to the manufacturer and examined.Contaminants were found on the exterior of the device.No obvious debris was found within the inside of the cannulated obturator.The device was examined while being backlit and a small dot near its tip was found when viewed extremely close.The exterior contaminants were cleaned away, and the device was sonicated within a graduated cylinder.No contaminants were located within the sonicated water or were found to be expelled from the interior of the obturator.Upon further examination the dot was still present.The obturator had its tip removed for a close examination of the object.Several air bubbles were noted in the tip of the device once removed.No debris was found.The object in the account's pictures is believed to be an oem deformation which, when back lit cast the shadow during use in the field.No debris was found.Unable to confirm account complaint.

• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY, 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: 5419422
• MDR Text Key: 38455313
• Report Number: 2134070-2016-00009
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043592
• 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: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: ETH2B5LT
• Device Catalogue Number: ETH2B5LT
• Device Lot Number: 1895306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 02/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• 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