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	Insufficient Information (4580)
Date of Event	10/07/2025
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 during a case light was turning off and they were unable to turn it back on.The led ring around the light port was on and the audible beep would sound when trying to turn the light back on, but the light would not turn on.No other information was available regarding troubleshooting steps or patient/staff impact.They switched out the box during the case and the replacement light box worked with the light cord they had been using.
Additional Manufacturer Narrative
Alleged failure: it was reported that the l11 light source lost power during a case.No other information was available regarding troubleshooting steps or patient/staff impact.The unit was given to the biomed shop with a note saying that it lost power during a case.He was unable to test it himself and needs to send it in for repair.Update- the issue that was happening during the case was not that the box itself was turning off, but that the light was turning off during the case.They then had problems getting the light to turn back on.The led ring around the light port was on and the audible beep would sound when trying to turn the light back on, but the light would not turn on.They switched out the box during the case and the replacement light box worked with the light cord they had been using.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root cause/s could be calibration error and/or bad reed switch on a safelight cable.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that during a case light was turning off and they were unable to turn it back on.The led ring around the light port was on and the audible beep would sound when trying to turn the light back on, but the light would not turn on.No other information was available regarding troubleshooting steps or patient/staff impact.They switched out the box during the case and the replacement light box worked with the light cord they had been using.

• 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: 23396092
• Report Number: 0002936485-2025-00898
• Device Sequence Number: 9871889
• Product Code: OWN
• UDI-Device Identifier: 07613327455915
• UDI-Public: 07613327455915
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K182160
• 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): 12/30/2025

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: 0220230300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 10/27/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2019
• 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