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 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

Regarding medwatch form# mw5060811 that was sent to sterilmed and received on 4/18/2016.According to this form the event description is "surgeon was using a reprocessed trocar, and when removed a small piece of plastic was in the aperture where the trocar was inserted." there was no information as to the end user's information to obtain additional information.There was no location nor was there any information on the date of event or patient's condition.This 3500a form is being submitted due to the lack of information and from the event description a medical device defect has occurred while used inside the patient.

• 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; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 5643584
• MDR Text Key: 44850810
• Report Number: 2134070-2016-00026
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• PMA/PMN Number: K043592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 04/18/2016

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: 1892959
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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