MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE 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	11/27/2024
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: "during the process of arthroscopic shoulder arthroplasty, the endoscope system lens suddenly went black and no image was visible, forcing the surgery to be paused.Restarting the system has not yet resolved the issue.Subsequently, another set of endoscopic system was replaced to complete the surgery.The device was repaired by a third party.".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 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.
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): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; burnaby; san jose CA 95138
• Manufacturer (Section G): NOVADAQ TECHNOLOGIES; 8329 eastlake drive, unit 101; burnaby; british columbia V5A 4 W2; CA V5A 4W2
• Manufacturer Contact: chester rebugio ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20982311
• Report Number: 3012345110-2024-00003
• Device Sequence Number: 9045906
• 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): 03/07/2025

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: 12/02/2024
• Supplement Date Received by Manufacturer: 12/02/2024
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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