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

Catalog Number	0220240300
Medical Device Problem Codes	Overheating of Device (1437); Electrical Shorting (2926); Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
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 fire caused from the distal end of cord unit.Unit turned itself off twice during case.Procedure completed using same device.There was full loss of light for 2 minutes probably and rebooting the light source fixed the problem each time.Device rebooting was observed after drape burn.Hence there is a thermal event and loss of light.
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: fire from the distal end of cord.Probable root cause: receptacle board leaf spring poor contact to contact ring, esst voltage malfunction, esd shock to contact ring, poor alignment of cable in jaw, assembly/grounding, light engine malfunction, main board malfunction, receptacle board malfunction, front board malfunction, damaged/missing esst spring, communication with ccu, overheating, power supply malfunction, software malfunction, hf/rf interference security attack to: - device settings - uc1 on main board - uc2 on main board - uc3 on main board - receptacle board - ccu usb ports - hub port - service port - device controls - uc1 programming port - uc2 programming port - uc3 programming port - receptacble board prog.Port - light engine - debug device functionality - physical location of l12 - l12 firmware operating system.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that fire caused from the distal end of cord unit.Unit turn itself off twice during case.Procedure completed using same device.There was full loss of light for 2 minutes probably and rebooting the light source fixed the problem each time.Device rebooting was observed after drape burn.Hence there is a thermal event and loss of light.

• 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: 23830498
• Report Number: 0002936485-2025-00989
• Device Sequence Number: 20100584
• Product Code: OWN
• UDI-Device Identifier: 07613327572124
• UDI-Public: 07613327572124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K230754
• 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): 03/27/2026

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: 0220240300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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