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 Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, the covering of the hub's bottom is fraying - it is not a clear cut of the edges.The consequence is that some small pieces of the "paper" has been laying on the or table.This could create the situation where these "paper pieces" could potentially fall inside the patient.No patient injured, no extension of incision or surgery time, no blood loss, no tissue damage, no change of procedure, nothing fell into cavity, no reinforcement material used.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of two photographs of a device opened by 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 device.The visual inspection of the photograph demonstrates a frayed covering on the bottom of the device.Based on the evaluation of the returned photos engineering was unable to confirm the reported condition.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 quality specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.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: 5200753
• MDR Text Key: 30619392
• Report Number: 2647580-2015-00774
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K062779
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2015
• 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: 10/29/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1