MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG PRECISION LED LIGHT SOURCE; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Catalog Number	0220220000
Medical Device Problem Codes	Material Integrity Problem (2978); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
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 there was loss of light.
Event or Problem Description
It was reported that there was loss of light.
Additional Manufacturer Narrative
The device was not received for investigation at stryker endoscopy because it was repaired locally in stryker france the technical service report indicates: fault : error message e2 and blue light repair level : 1 action taken : replace led module replace actuator tests : function test calibration general inspections qip" probable root cause: front board malfunction touch screen malfunction main board malfunction power supply malfunction ac inlet board malfunction power button rod damaged inadequate air flow sidne port malfunction poor workmanship use errors electromagnetic interference (emi) from rf communication, hf surgical instruments, esd, or power surge the reported failure mode will be monitored for future reoccurrence.

• Brand Name: PKG PRECISION LED LIGHT SOURCE
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21251810
• Report Number: 0002936485-2025-00063
• Device Sequence Number: 18411239
• Product Code: FCW
• UDI-Device Identifier: 07613327051322
• UDI-Public: 07613327051322
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: 0220220000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 04/27/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 05/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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