MAUDE Adverse Event Report: NOVADAQ TECHNOLOGIES PINPOINT CAMERA HEAD; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	PC9002
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device lost image during a procedure, causing a 5 minute delay.There were no reported adverse consequences as a result.
Additional Manufacturer Narrative
Alleged failure: "eib, jc, onsite, no image, po# sjc0015807" probable root cause: reported failure mode was reproduced and probable root cause is due to damaged camera cable.The connector plug housing was bulging and making it difficult to insert securely without additional force.The camera cable was identified as a previous rev.B part with epoxy that was prone to swelling when exposed to moisture during reprocessing.This issue was addressed with eco084152, which changed the potting epoxy to a medical grade formulation resistant to moisture and temperature changes.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the device lost image during a procedure, causing a 5 minute delay.There were no reported adverse consequences as a result.

• Brand Name: PINPOINT CAMERA HEAD
• 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 V5A 4 W2; CA V5A 4W2
• Manufacturer Contact: kelsey barla ; 8329 eastlake drive, unit 101; burnaby; british columbia, CA V5A 4-W2 ; CA V5A 4W2 ; 8006244422
• MDR Report Key: 15312221
• Report Number: 3012345110-2022-00007
• Device Sequence Number: 20200516
• Product Code: GCJ
• UDI-Device Identifier: 00858701006551
• UDI-Public: 00858701006551
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/31/2022

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: PC9002
• Device Catalogue Number: PC9002
• 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: 08/18/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 10/31/2022
• 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