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	07/24/2025
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 the light source was flickering when using the 1588 and 1688 cameras, so the recording of each camera when in use was checked, and the light source operation was inspected by connecting the light cable to the l10 and l11 cameras.The flickering was confirmed to be flickering light output.Additional information regarding the event, such as a potential for a full loss of light and the duration could not be obtained.
Event or Problem Description
It was reported that the light source was flickering when using the 1588 and 1688 cameras, so the recording of each camera when in use was checked, and the light source operation was inspected by connecting the light cable to the l10 and l11 cameras.The flickering was confirmed to be flickering light output.Additional information regarding the event, such as a potential for a full loss of light and the duration could not be obtained.
Additional Manufacturer Narrative
The device was not received for investigation at stryker endoscopy because it was repaired locally in japan.The technical service report indicates: test results: reproduction of the phenomenon could not be confirmed in both 1588 and 1688 work content: recording measures on the 1588 side (when an), confirmation, connecting light cables to l10 and l11 to operate the light source, and recognition confirmation.Result: we have confirmed that the light source unit is working properly.Please continue to monitor progress.Probable root cause: damaged light cable.Damaged scope.Damaged coupler.Damaged leds.Main board malfunction.Loose / misaligned jaw assembly.Light engine/ light pipe malfunction or damaged.Bent esst contact.Inconsistent esst contact.Camera head communication.Front board malfunction.Touch panel malfunction.Power supply malfunction.Thermal switch malfunction.Ac inlet board malfunction.Inadequate air flow.Sidne port malfunction.Poor workmanship.Inadequate calibration.Use errors.Electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge.The reported failure mode will be monitored for future reoccurrence.

• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22868655
• Report Number: 0002936485-2025-00716
• Device Sequence Number: 18050265
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

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?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2021
• 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