MAUDE Adverse Event Report: Stryker Endoscopy-San Jose PKG PRECISION LED LIGHT SOURCE - INTERNATIONAL KIT; light source, fiberoptic, routine

Catalog Number	0220220000I
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2026
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 after installing the fiber optic cable, no light is being detected from the precision light source.

• Brand Name: PKG PRECISION LED LIGHT SOURCE - INTERNATIONAL KIT
• Common Device Name: light source, fiberoptic, routine
• 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 ; +1(408)754-2000
• MDR Report Key: 25383260
• Report Number: 0002936485-2026-00355
• Device Sequence Number: 15620836
• Product Code: FCW
• UDI-Device Identifier: 07613327051322
• UDI-Public: (01)07613327051322
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K082813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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: 0220220000I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 06/03/2026
• Supplement Report FDA Received Date: 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2022
• 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