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 05/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a laparoscopic right hemicolectomy, the button was pushed during procedure, but the lamp did not turn on.In addition, trocar wipe's tip has been gone.New one was opened to correct the problem.Nothing fell into the cavity.No one knows when the tip was missing or if it was missing from the packaging; it was already missing when they noticed it during procedure.

Manufacturer Narrative

(b)(4).Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account and two photographs from the account.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, engineering review of the product, and an evaluation of the returned sample.The initial visual inspection of the instrument by the pmv investigator noted that the valve seal was closed; surfactant was present in the canister.The internal components noted corrosion of the batteries and damage to the foam housing.Inspection of the photographs showed the tip of the trocar wipe had been broken off the end of the device and the middle of the trocar wipe was bent.Engineering verified that the valve cap was broken.Visual and functional testing of the returned sample confirmed the product did not meet quality release specifications that were tested due to corroded batteries.A review of the device history record indicates this device lot number was released meeting all quality release specifications at the time of manufacture.The root cause of the corroded batteries was determined to be a result of a manufacturing activity and a product enhancement and a process improvement has been initiated to prevent this condition from recurring.The root cause of corroded batteries is related to a difficulty in the assembly process of the cap and valve.The difficulty in the assembly process is due to the design of the valve.When the cap and valve are not assembled properly, the valve pinches and leakage occurs.This condition has been brought to the attention of the appropriate manufacturing personnel.Replication of the disengaged tip of the trocar wipe can occur if the trocar tip is used or inserted forcefully into the trocar.The file will be closed as design error with a secondary finding of a misuse of the product.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: 5697366
• MDR Text Key: 46494546
• Report Number: 2647580-2016-00298
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 21345
• Device Catalogue Number: 21345
• Device Lot Number: P6A0506GX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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