MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1788 4K CAMERA HEAD C-MOUNT; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1788210105
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that there was image failure and loose contact during surgery.A replacement was available to be used to complete the procedure.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.No further attempts to retrieve the device are required.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.Alleged failure: loss of image.Probable root cause: faulty solder joints in video path.Faulty prism board or connectors.Faulty xboard or ch cable connectors.Break in ch cable core.Faulty hdmi cable.Faulty ccu power supply.Internal ccu cable failure - power and/or communication.Improper/no fuse installed.Ac inlet board.Main board - video processor.Digital board - fpga.Transition board - coax connector.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.Poor system grounding.Improper ccu timing.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was image failure and loose contact during surgery.A replacement was available to be used to complete the procedure.

• Brand Name: PKG 1788 4K CAMERA HEAD C-MOUNT
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22292251
• Report Number: 0002936485-2025-00558
• Device Sequence Number: 15570032
• Product Code: GCJ
• UDI-Device Identifier: 07613327580037
• UDI-Public: 07613327580037
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K230605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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: 1788210105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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