MAUDE Adverse Event Report: COOK MEDICAL COOK MEDICAL; EXTRA STIFF J WIRE

Model Number G03750

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/23/2016

Event Type  malfunction  

Event Description

The wire was straight with no j curve.Either wrong packaging or defect.

• Brand Name: COOK MEDICAL
• Type of Device: EXTRA STIFF J WIRE
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47402
• MDR Report Key: 6185906
• MDR Text Key: 62828976
• Report Number: MW5066776
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G03750
• Device Lot Number: 6936303
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR