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	08/21/2025
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 device went on standby during case and the surgical screen went black.The patient was awake.Staff had to turn the light source back on to continue.Case successfully completed.Slight delay in case.
Event or Problem Description
It was reported that the device went on standby during case and the surgical screen went black.The patient was awake.Staff had to turn the light source back on to continue.Case successfully completed.Slight delay in case.
Additional Manufacturer Narrative
Alleged failure: went on standby during case and surgical screen went black.Patient was awake.Staff had to turn the light source back on to continue.Case successfully completed.Slight delay in case.The failure(s) identified in the investigation is consistent with the complaint record.Probable root cause: leaf spring issue.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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22925899
• Report Number: 0002936485-2025-00751
• Device Sequence Number: 21389979
• Product Code: OWN
• UDI-Device Identifier: 07613327455915
• UDI-Public: 07613327455915
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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