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 07/13/2016

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 during a procedure, debris was found in the device.It is reported that the patient was being monitored for adverse reaction, but at the time of this report, no patient harm or consequences were noted.

Manufacturer Narrative

The account supplied photos showing the debris inside the obturator, along with the debris missing from the camera view in the field.When the device was returned, the rear port was uncovered and no debris was found to be present.The debris in the photos supplied by the account is reddish/brown which is inconsistent with organic debris that has been exposed to eo sterilization.The photos supplied by the account confirm that debris was present during use in the field, though no analysis of the debris could be completed due to the debris being missing when returned.

• 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 parway; suite 2; plymouth, MN 55446 ; 7634888348
• MDR Report Key: 5876396
• MDR Text Key: 52111810
• Report Number: 2134070-2016-00057
• 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: 09/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2017
• Device Model Number: ETH2B5LT
• Device Catalogue Number: ETH2B5LT
• Device Lot Number: 1918455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2016
• 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