MAUDE Adverse Event Report: Stryker Endoscopy-San Jose PKG SAFELIGHT HENKE DYONICS STORZ SCOPE ADAPTER; Light source, fiberoptic, routine

Catalog Number	0233050087
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pediatric laparoscopic procedure, the light output from the light source unit suddenly turned off.Although the front panel remained illuminated, pressing the on button did not restore the light output.The ring indicator and light intensity display on the panel remained lit, and the light intensity could still be adjusted.When the power to the unit was turned off and then on again, the light output was restored.However, after being used for a period of time, the same issue recurred.This phenomenon reportedly occurred approximately 3 to 5 times during the procedure.The exact duration of each occurrence is unknown.The light output did not resume automatically.In each instance, the issue was resolved by turning the device off and back on.The procedure was completed with the same device.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known since the lot/serial number of the device is not reported at this time.However, should it become available it will be provided in future reports.

• Brand Name: PKG SAFELIGHT HENKE DYONICS STORZ SCOPE ADAPTER
• 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: 50889799
• Report Number: 0002936485-2026-01095
• Device Sequence Number: 18819465
• Product Code: FCW
• UDI-Device Identifier: 07613327161618
• UDI-Public: 07613327161618
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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: 0233050087
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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