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 been returned to the manufacturer at the time of this report.A supplemental report will be sent once the device evaluation is completed if the device is returned.The device history record has been reviewed and no discrepancies were found.

Event Description

It was reported that during a lap chole procedure, visible debris was noticed.The device was removed from the field and a new device was used.There was no patient injury or consequence reported.

Manufacturer Narrative

The device was returned to the manufacturer in a used condition with slight contaminants present indicating exposure.The device was evaluated and no debris could be found inside the trocar sleeve or the obturator.During the investigation a brush was inserted into both the obturator and sleeve and there were no signs of debris on the brush when the brush was removed.Unsure if the debris had been removed at the account or fell out of the device during transit and was lost.The device was function tested and passed the leak test.Unable to confirm accounts reported issue as there were no signs of debris found in the returned device.The device history report was reviewed with no discrepancies found.

• 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: 5315779
• MDR Text Key: 34033796
• Report Number: 2134070-2015-00058
• 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: 01/18/2016

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: 08/30/2016
• Device Model Number: ETH2B5LT
• Device Catalogue Number: ETH2B5LT
• Device Lot Number: 1880507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2015
• 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