MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG L11 LED LIGHT SOURCE WITH AIM; CONFOCAL OPTICAL IMAGING

Catalog Number	0220230300
Medical Device Problem Codes	Connection Problem (2900); Optical Problem (3001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/26/2025
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, l11 shut off during a case.When they tried to turn on the l11, the ring around the light cable was on and blinking but the power button was greyed out.They were not able to turn it on and when they were troubleshooting it, they checked to see if the light cable port was damaged or lose and if the auto light feature was off.They tested a new light cable and the port looked fine.They also confirmed that the auto light feature was off, but the power button was still greyed out.Case was completed and there was patient care delay but was not reported if there was harm.The case was also wrapping up while they were troubleshooting.Therefore, there was a loss of light.
Event or Problem Description
It was reported that l11 shut off during a case.When they tried to turn on the l11, the ring around the light cable was on and blinking but the power button was greyed out.They were not able to turn it on and when they were troubleshooting it, they checked to see if the light cable port was damaged or lose and if the auto light feature was off.They tested a new light cable and the port looked fine.They also confirmed that the auto light feature was off, but the power button was still greyed out.Case was completed and there was patient care delay but was not reported if there was harm.The case was also wrapping up when while they were troubleshooting.Therefore, there was a loss of light.
Additional Manufacturer Narrative
Three attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.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: shut off during a case.Probable root cause: light engine malfunction, main board, receptacle board, or front board malfunction, damaged or missing esst spring, incorrect/no communication with 1688, overheating, power supply malfunction, software malfunction, hf/rf interference, cybersecurity attack.The reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG L11 LED LIGHT SOURCE WITH AIM
• Common Device Name: CONFOCAL OPTICAL IMAGING
• 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23882514
• Report Number: 0002936485-2025-01008
• Device Sequence Number: 17320192
• Product Code: OWN
• UDI-Device Identifier: 07613327455915
• UDI-Public: 07613327455915
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K182160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 0220230300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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