MAUDE Adverse Event Report: RICHARD WOLF MEDICAL EGRESS CANNULA

Model Number 8302.09

Device Problem Material Integrity Problem (2978)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 04/24/2014

Event Type  Injury  

Event Description

The pt went to his physician with complaints of left knee pain, he was treated with medication and f/u two weeks later.On f/u visit, the pain persisted and an x-ray was taken.A foreign body was noted on x-ray, the surgery to remove the foreign body occurred on (b)(6) 2014.The foreign body was a 1.5 cm metallic tube with holes, similar to a cannula tip.The pt was questioned about past knee surgeries and he states he had only one prior surgery at this same center on (b)(6) 2012.The surgical record was reviewed and the staff was interviewed about any reported broken or missing cannulas, but none were reported.

• Brand Name: EGRESS CANNULA
• Type of Device: CANNULA
• Manufacturer (Section D): RICHARD WOLF MEDICAL; 2573 momentum place; chicago IL 60689 532
• MDR Report Key: 3818014
• MDR Text Key: 4447382
• Report Number: MW5036118
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8302.09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 98