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

Catalog Number	PC9002
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
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 loss of image during procedure.
Additional Manufacturer Narrative
Alleged failure: "the device was used for arthroscopic shoulder joint shaping.During the surgery process, the screen suddenly turned black, the operator had to stop the surgery and returned the device, however there were still problem of the screen.Then they replaced to use another device to complete the surgery." probable root cause/s: product was not returned to stryker endoscopy.Based on the reported symptoms, reported issue can be caused by a number of electrical and/or mechanical issues affecting both the the vpi and pinpoint camera and various connection points and electrical components between the two devices.Probable root cause remains unknown but can include the following: 1) damaged pinpoint camera cable 2) electrical fault or loose connection with internal camera components 3) damage to vpi connector cable socket 4) damage and/or electrical fault to internal vpi components 5) display malfunction this complaint investigation was closed based on the device not received.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.Updating to reference correct fda registration number : fda registration 3012345110 - endoscopy (novadaq) h3 other text : 81.
Event or Problem Description
It was reported that there was loss of image during procedure.

• 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 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: 18279449
• Report Number: 0002936485-2023-01223
• Device Sequence Number: 12309426
• Product Code: GCJ
• UDI-Device Identifier: 00858701006551
• UDI-Public: 00858701006551
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2024

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: PC9002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 02/02/2024
• 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
• Patient Sex: Unknown