MAUDE Adverse Event Report: COVIDIEN CLEARIFY VISUALIZATION SYSTEM; CLARIFY

Model Number 21-345

Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/11/2018

Event Type  malfunction  

Event Description

When handing off supplies after draping for the procedure the clarify unit dripped brownish fluid onto the drape.The drapes were removed and new supplies opened.The supplies were sequestered for examination by quality department team.The patient was not harmed.

• Brand Name: CLEARIFY VISUALIZATION SYSTEM
• Type of Device: CLARIFY
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 7472559
• MDR Text Key: 106970713
• Report Number: MW5076887
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• 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: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 21-345
• Device Catalogue Number: (01)10884521213562
• Device Lot Number: P8A1149HX
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 118