MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK VISTA OPTICAL PORT 5MM X 100MM RIDGED

Catalog Number 40511R

Device Problems Break (1069); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2013

Event Type  malfunction  

Event Description

The event is reported as: the tip of the trocar broke when the surgeon used the wrong size trocar with the device.Patient's current condition is fine.No injury reported.

Manufacturer Narrative

Device sample not returned to manufacturer in time for this report.

• Brand Name: WECK VISTA OPTICAL PORT 5MM X 100MM RIDGED
• Type of Device: OPTICAL PORT
• Manufacturer (Section D): TELEFLEX MEDICAL; tecate ; MX
• Manufacturer Contact: elaine burkle, rn ; p.o. box 12600; durham, NC 27709 ; 9194334957
• MDR Report Key: 3703021
• MDR Text Key: 4263478
• Report Number: 3003898360-2014-00041
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 40511R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2013
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1