MAUDE Adverse Event Report: STERILMED, INC.; ETHICON ENDO SURGERY ENDOSCOPIC TROCARS

Model Number ETH2B5LT

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2016

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 unable to be reviewed as no lot number was available.

Event Description

It was reported that during a procedure tissue was found inside of the trocar device.No patient harm or consequences were reported.Additional information was requested, including the device part number involved, but it was reported that there was not any additional information available.

Manufacturer Narrative

The device was returned to the manufacturer and debris was found inside the cannulated obturator.The debris was extracted and examined under high magnification.The debris displayed traits that were not consistent with organic debris that had undergone eo sterilization.The debris did not flake apart but rather curled upon itself.The origin of the debris is uncertain.As the account did not provide any of their pictures or images of the debris during their use, it cannot be confirmed that the debris extracted from the obturator was the debris noted by the account.The sample of the debris was too small to submit for chemical analysis.It may have been rubbed/cut off the handle of the obturator.

• Type of Device: ETHICON ENDO SURGERY ENDOSCOPIC TROCARS
• Manufacturer (Section D): STERILMED, INC.; 11400 73rd ave n; maple grove
• Manufacturer Contact: jason anderson ; 5010 cheshire parway; suite 2; plymouth, MN 55426 ; 7634888348
• MDR Report Key: 5695680
• MDR Text Key: 47651828
• Report Number: 2134070-2016-00037
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/05/2016

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 Model Number: ETH2B5LT
• Device Catalogue Number: ETH2B5LT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2016
• Initial Date FDA Received: 06/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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