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

Catalog Number	PC9001
Medical Device Problem Codes	No Device Output (1435); Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that there was a thermal event.
Additional Manufacturer Narrative
Alleged failure: "cib drew, rep.Short circuited, quickly turned off, burning smell temp" probable root cause/s: reported failure mode was confirmed.Vpi would not power up and no standby amber led light was observed on the front panel.Power supply 24v output was reading at 0v with rear mains panel switch on.Probable root cause is likely due to a faulty power supply.The product was returned for investigation and the reported failure mode was confirmed.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that there was a thermal event.

• Brand Name: VIDEO PROCESSOR/ILLUMINATOR (VPI)
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): NOVADAQ TECHNOLOGIES; 8329 eastlake drive, unit 101; burnaby; british columbia 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18530806
• Report Number: 3012345110-2024-00001
• Device Sequence Number: 7698362
• Product Code: GCJ
• UDI-Device Identifier: 00858701006049
• UDI-Public: 00858701006049
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K150956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: PC9001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown