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	Optical Problem (3001); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
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 light disappeared about two hours into the procedure.Procedure completed using replacement.They have inspected the fse and were unable to reproduce the reported defect.They are currently conducting ongoing observation at the facility.
Additional Manufacturer Narrative
It was reported that the device was not available for evaluation.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: light disappeared about two hours into the procedure.Procedure completed using replacement.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 product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that light disappeared about two hours into the procedure.Procedure completed using replacement.They have inspected the fse and were unable to reproduce the reported defect.They are currently conducting ongoing observation at the facility.

• 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: 24700344
• Report Number: 0002936485-2026-00183
• Device Sequence Number: 10557194
• Product Code: OWN
• UDI-Device Identifier: 07613327455915
• UDI-Public: 07613327455915
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K182160
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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): Follow-Up
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2021
• 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