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 or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Since the lot number was not provided, this information cannot be determined.

Event Description

According to the reporter, during a laparoscopic procedure for uterus malignant tumor, a metallic piece was found.It seemed to be a part of devices used during the procedure.No patient harm.The broken piece was found on a mayo instrument tray, not inside the patient's cavity; nothing fell into patient's cavity was from the ligasure device.M.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation of one clearify visualization system opened by the account and two photographs.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 inspection of the device and internal components noted no abnormalities.No components were missing or disengaged.Additionally, the valve was found to be opened.Two photographs provided by the account show a metallic component.The component does not belong to the device.During functional evaluation, tactile inspection of the power switch confirmed that the switch was fully activated.The device was dismantled and new batteries were connected to the device.The led turned on and the device was warming.Visual and functional testing of the returned product confirmed the product met quality release specifications and the reported condition was not confirmed.A review of the device history record could not be performed because the lot number was not provided.However, records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all medtronic quality specifications at the time of manufacture.A review of the current historical complaint data reveals no trend for a device related failure or complaint mode for this condition.No enhancements or improvements were generated for the reported condition.Should new information become available, the file will be re-opened and the investigation summary amended as appropriate.

• 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: 5798062
• MDR Text Key: 49644075
• Report Number: 2647580-2016-00417
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21345
• Device Catalogue Number: 21345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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