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

Model Number	PC9000
Medical Device Problem Codes	No Device Output (1435); Unintended Electrical Shock (4018)
Health Effect - Clinical Codes	Shock (2072); Electric Shock (2554)
Date of Event	10/11/2021
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 the user experienced electric shock.
Event or Problem Description
It was reported that the user experienced electric shock.
Additional Manufacturer Narrative
Alleged failure: "it was reported that "(engineer) installed it on the stack first thing this morning, completed an electrical safety test and function check.On pre-use check the theatre staff found that the loan pc9001, sn (b)(6) would not switch on.Initial reporter (staff at account) was called to troubleshoot, as they inspected the device it gave them quite a significant electric shock.They can also confirm it does not switch on."" probable root cause/s: as reported, vpi could not power up.The failure was caused by a power supply failure.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 or Problem Description
It was reported that the user experienced electric shock.
Additional Manufacturer Narrative
Updating section d3: manufacturer entity g1: manufacturing site for devices fda registration number to 3012345110 - endoscopy (novadaq).

• 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 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: 12789401
• Report Number: 0002936485-2021-00620
• Device Sequence Number: 17379933
• Product Code: GCJ
• UDI-Device Identifier: 00858701006049
• UDI-Public: 00858701006049
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K150956
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2024

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 Model Number: PC9000
• Device Catalogue Number: PC9001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 10/12/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/22/2021; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown