MAUDE Adverse Event Report: STERILMED TROCAR

Model Number 2B5LT

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/09/2016

Event Type  malfunction  

Event Description

Surgeon was using a reprocessed trocar, and when removed a small piece of plastic was in the aperture where the trocar was inserted.(b)(6).

• Brand Name: TROCAR
• Type of Device: TROCAR
• Manufacturer (Section D): STERILMED; 5010 cheshire parkwa; suite 2; plymouth MN 55446
• MDR Report Key: 5491631
• MDR Text Key: 40052740
• Report Number: MW5060811
• Device Sequence Number: 1
• Product Code: DRC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/04/2016

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: 2B5LT
• Device Catalogue Number: 2B5LT
• Device Lot Number: 1892959
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2016
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 95