MAUDE Adverse Event Report: COVIDIEN, FORMERLY USSC PUERTO RICO INC CLEARIFY VISUALIZATION SYSTEM; ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY

Model Number 21345

Device Problems Detachment Of Device Component (1104); Product Quality Problem (1506)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).(b)(6).

Event Description

According to the reporter, while using the device on their robot the customer experience that the hole for the camera has gotten much smaller, so when they introduced the camera into the device, they had to push much harder than before.Therefore the device opened in the bottom, the paper lid that holds all cables and batteries inside was pushed opened.

• Brand Name: CLEARIFY VISUALIZATION SYSTEM
• Type of Device: ANTI FOG SOLUTION AND ACCESSORIES, ENDOSCOPY
• Manufacturer (Section D): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer (Section G): COVIDIEN, FORMERLY USSC PUERTO RICO INC; building 911-67; sabanetas industrial park; ponce PR 00731
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven
• MDR Report Key: 6100607
• MDR Text Key: 59844985
• Report Number: 2647580-2016-00948
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K062779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 21345
• Device Catalogue Number: 21345
• Device Lot Number: P6F0414GX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1