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	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/16/2024
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 a loss of light.
Additional Manufacturer Narrative
Alleged failure: delay.Malfunction of light turning off multiple times.Troubleshooted with a different light cord adapter, which worked for a short period of time.Then an error code e-22 popped up on the screen twice after rebooting console.The failure(s) identified in the investigation is consistent with the complaint record.Probable root causes: damaged main board.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that there was a 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21154204
• Report Number: 0002936485-2025-00033
• Device Sequence Number: 18474018
• Product Code: OWN
• UDI-Device Identifier: 07613327572124
• UDI-Public: 07613327572124
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/08/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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