MAUDE Adverse Event Report: NOVADAQ TECHNOLOGIES PINPOINT LAPAROSCOPE - 10MM, STANDARD, 0 WITH WOLF AND STORZ ADAPTOR; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	SC9104
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2022
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 during a procedure the image quality was cloudy/grainy.A replacement device was used to complete the case, resulting in a 1-2 minute delay while connecting the replacement.There was a patient involved; however, they did not experience any adverse consequences.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.The reported failure mode will be monitored for future reoccurrence.Alleged failure: image quality was cloudy/grainy.Probable root cause: discolouration of image (ex.Blue tinge), fogginess due to moisture, damage to lens surfaces, obstruction within field of view, scope out of focus.Manufacture date is not known.
Event or Problem Description
It was reported that during a procedure the image quality was cloudy/grainy.A replacement device was used to complete the case, resulting in a 1-2 minute delay while connecting the replacement.There was a patient involved; however, they did not experience any adverse consequences.

• Brand Name: PINPOINT LAPAROSCOPE - 10MM, STANDARD, 0 WITH WOLF AND STORZ ADAPTOR
• 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: benjamin ly ; 8329 eastlake drive, unit 101; burnaby; british columbia, CA V5A 4-W2 ; CA V5A 4W2 ; 8006244422
• MDR Report Key: 14940367
• Report Number: 3012345110-2022-00003
• Device Sequence Number: 6214936
• Product Code: GCJ
• UDI-Device Identifier: 00858701006056
• UDI-Public: 00858701006056
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/06/2022

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: SC9104
• Device Catalogue Number: SC9104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/01/2022
• Supplement Date Received by Manufacturer: 07/01/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 10/06/2022
• 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
• Patient Sex: Unknown