MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG L11 LED LIGHT SOURCE WITH AIM; CONFOCAL OPTICAL IMAGING

Catalog Number	0220230300
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
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 l11 light source sn (b)(6) shut off during case, caused a 10 minute delay.There was full loss of light for approximately 30 seconds before getting another source.Case completed with the help of replacement device from another room.No information about medical intervention is provided.
Event or Problem Description
It was reported that l11 light source sn (b)(6) shut off during case, caused a 10 minute delay.There was full loss of light for approximately 30 seconds before getting another source.Case completed with the help of replacement device from another room.No information about medical intervention is provided.
Additional Manufacturer Narrative
Alleged failure: l11 lightsource sn (b)(6) shut off during case, caused a 10 minute delay.Update- full loss of light was experienced for approximately 30 seconds before getting another source.Case completed with the help of replacement device from another room.There was no medical intervention.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.Probable root cause: bad reed switch on the safe light cable, and/or not fully seated light cable.Advise to re-calibrate the light source unit.The product was returned for investigation and the 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: arsalan rizvi ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 23350924
• Report Number: 0002936485-2025-00859
• Device Sequence Number: 9131027
• Product Code: OWN
• UDI-Device Identifier: 07613327455915
• UDI-Public: 07613327455915
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 12/12/2025

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: 09/26/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/22/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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