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 Codes	Optical Problem (3001); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
The adapter was not recognized and the light source stopped working.The permanent magnet had lost its magnetic force.Therefore, there was loss of light.
Event or Problem Description
The adapter was not recognized and the light source stopped working.The permanent magnet had lost its magnetic force.Therefore, there was loss of light.
Additional Manufacturer Narrative
Multiple attempts have been made to retrieve the device for evaluation, and it is yet to be received in-house.This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: no light output probable root cause: broken optical fibers, poor light cable alignment in jaw, residue on fiber tip, nonuniform light output intermittent electrical component contact in safelight circuit, reed switch assembly malfunction magnet missing from safelight adapter use error the reported failure mode will be monitored for future reoccurrence.D4 lot # was updated.

• 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22594022
• Report Number: 0002936485-2025-00663
• Device Sequence Number: 13056343
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2025

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: 0233050087
• Device Lot Number: 22E5086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2025
• 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