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

Catalog Number	PC9002
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2019
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 there was image loss during procedure.The procedure was completed successfully with no reports of adverse consequences.
Event or Problem Description
It was reported that there was image loss during procedure.The procedure was completed successfully with no reports of adverse consequences.
Additional Manufacturer Narrative
Alleged failure: "no picture is displayed.There is a loose connection.Even after switching off and on and re-plugging the camera, no picture was displayed at times." probable root cause: based on the event description, it is believed the failure was caused by a faulty camera cable.When the camera cable sustains physical internal damage it can be difficult to observe visually and lead to intermittent signal transmission as reported.No further investigation can be conducted without product return.The device was not returned for investigation and the reported failure mode was not confirmed.The reported failure mode will be monitored for future re occurrence.For information and warnings related to the proper use and maintenance of this device, please reference and adhere to information presented in the associated product ifu.The device manufacturer date is not known.H3 other text : 81.

• 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
• MDR Report Key: 8714593
• Report Number: 3012345110-2019-00007
• Device Sequence Number: 2522968
• Product Code: GCJ
• UDI-Device Identifier: 00858701006551
• UDI-Public: 00858701006551
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: PC9002
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/19/2019
• Supplement Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1