MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG 1788 CAMERA CONTROL UNIT CCU; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Catalog Number	1788010000
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation is complete.
Event or Problem Description
It was reported that there was loss of image.
Event or Problem Description
It was reported that there was loss of image.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: loss of image confirmed failure: dx codes verbiage: software reprogram softwar upgrade 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.

• Brand Name: PKG 1788 CAMERA CONTROL UNIT CCU
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 20970903
• Report Number: 0002936485-2024-00964
• Device Sequence Number: 4032867
• Product Code: GCJ
• UDI-Device Identifier: 07613327580013
• UDI-Public: 07613327580013
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K230605
• 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): 03/10/2025

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: 1788010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2023
• 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