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 Unspecified Infection (1930)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

The device was returned to the manufacturer, stating that there was debris inside the obturator.When examined, no debris was currently present inside the obturator, however a small piece of debris resembling the images returned by the account was found on the handle of the device.When examined under magnification the characteristics of the debris resembled plastic instead of organic contaminants.The source of the debris is unknown.

Event Description

It was reported that during a laparoscopic colectomy and appendectomy the device appeared to have debris inside the obturator.The device was used, and the facility noted that there is a possible infection due to this.Upon request for further information, it was reported that received the normal antibiotic protocol, and that a week after the procedure, the patient experienced no changes in health.

• 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: 5480699
• MDR Text Key: 39689240
• Report Number: 2134070-2016-00016
• 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
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2016
• Initial Date FDA Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 95