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

Model Number 21345

Device Problem Detachment Of Device Component (1104)

Patient Problem Not Applicable (3189)

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Occurred during a robotic ventral hernia repair procedure.It was an out of box failure and the device was not used on the patient.The bottom of the hub came completely off the device.The bottom of the hub seemed to become unglued.A new one was opened to correct the condition.

Manufacturer Narrative

(b)(4).Device received for evaluation.Device evaluation pending.(b)(4).No further details regarding patient, product or procedure were provided by the reporter.

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one clearify visualization system.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.Visual and functional evaluation showed no abnormalities.The batteries were replaced and the device warmed properly.The file was concluded to be tested satisfactorily.Should new information become available, the file will be re-opened and reassessed at that time.

• 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, CT 06473 ; 2034925267
• MDR Report Key: 6034185
• MDR Text Key: 57816115
• Report Number: 2647580-2016-00827
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: 21345
• Device Catalogue Number: 21345
• Device Lot Number: P6G0679GX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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