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

Catalog Number	1788010000
Medical Device Problem Codes	No Display/Image (1183); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
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 loss of image.
Event or Problem Description
It was reported that there was loss of image.
Additional Manufacturer Narrative
Alleged failure: the pictures on the monitors simultaneously turned green.By switching out the ccu, the problem was solved.This happened mid case, surgeon was operating for awhile and then poof! right in the middle of their case all three screens went green.Another thing to add is when we try to reboot the ccu, it will not full boot up, it gets stuck on the loading screen forever.Garbled signal totally covered live image.The failures identified in the investigation is consistent with the complaint record.The probable root cause could be attributed to a digital board failure.Swapping out the board fixed the issues.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: 19671522
• Report Number: 0002936485-2024-00500
• Device Sequence Number: 20574220
• Product Code: GCJ
• UDI-Device Identifier: 07613327580013
• UDI-Public: 07613327580013
• Combination Product (Y/N): N
• 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): 09/17/2024

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: 1788010000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 07/03/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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