MAUDE Adverse Event Report: NOVADAQ TECHNOLOGIES VIDEO PROCESSOR/ILLUMINATOR (VPI); LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number PC9000

Device Problems Image Display Error/Artifact (1304); Optical Problem (3001)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/04/2022

Event Type  malfunction  

Event Description

It was reported that there was loss of image.

Manufacturer Narrative

Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.

Manufacturer Narrative

Alleged failure: "loss of image quality likely due to damage in the camera port connection." probable root cause/s: reported failure mode was confirmed and root cause is due to a faulty fvp board.The device was returned for investigation and the reported failure mode was reproduced.The reported failure mode will be monitored for future re occurrence.Manufacture date is not known.

Event Description

It was reported that there was loss of image.

Event Description

It was reported that there was loss of image.

Manufacturer Narrative

Correcting fda registration number from 0002936485 - endoscopy (san jose) to 3012345110 - endoscopy (novadaq).

• Brand Name: VIDEO PROCESSOR/ILLUMINATOR (VPI)
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): NOVADAQ TECHNOLOGIES; 8329 eastlake drive, unit 101; burnaby; british columbia CA V5A 4 W2; CA V5A 4W2
• Manufacturer (Section G): NOVADAQ TECHNOLOGIES; 8329 eastlake drive, unit 101; burnaby; british columbia CA V5A 4 W2; CA V5A 4W2
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15700410
• MDR Text Key: 306891308
• Report Number: 0002936485-2022-00618
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00858701006049
• UDI-Public: 00858701006049
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K150956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PC9000
• Device Catalogue Number: PC9001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/31/2022
• Supplement Dates Manufacturer Received: 10/05/2022; 10/05/2022
• Supplement Dates FDA Received: 12/12/2022; 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1