MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG L12 LED LIGHT SOURCE WITH AIM; CONFOCAL OPTICAL IMAGING

Catalog Number	0220240300
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on one of the cold lights (sn: (b)(6)), the nursing staff smelled something burning coming from the cold light and saw smoke.Therefore, there was a thermal event.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that on one of the cold lights (sn: (b)(6), the nursing staff smelled something burning coming from the cold light and saw smoke.Therefore, there was a thermal event.
Additional Manufacturer Narrative
Three attempts were made to retrieve the device for evaluation but the device was not returned.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: visible smoke coming from light source probable root cause: component overheating, main board, front board, or receptacle board malfunction, light engine malfunction, power supply malfunction, software malfunction, foreign material on proximal end of light cable the reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG L12 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: 23995818
• Report Number: 0002936485-2026-00006
• Device Sequence Number: 21465482
• Product Code: OWN
• UDI-Device Identifier: 07613327572124
• UDI-Public: 07613327572124
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K230754
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: Other
• Device Catalogue Number: 0220240300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2024
• 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