MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE L9000 LIGHTSOURCE INTERNATIONAL KIT; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Catalog Number	0220210000I
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was loss of light.
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
It was reported that there was loss of light.
Additional Manufacturer Narrative
The device was received at the local service facility for investigation.Reported by the customer: light source switched off mid-case summary of evaluation: cannot duplicate the fault.Touch screen buttons on lcd do not activate when pressed.No light output when light cable is connected action taken: lcd touch screen replaced main board replaced calibration completed soak tested passed all tests probable root cause: light cable optics leds main board jaw assembly bent esst contact inconsistent esst contact cable pull out camera head firewire cable software front board power supply thermal switch ac inlet board ac inlet filter touch screen workmanship inadequate air flow inadequate calibration excessive lint buildup inside the unit use errors the reported failure mode will be monitored for future reoccurrence.

• Brand Name: L9000 LIGHTSOURCE 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 - MHRA ORG ID:31333; 5900 optical court; san jose CA 95138
• Manufacturer Contact: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 16649528
• Report Number: 0002936485-2023-00261
• Device Sequence Number: 17654472
• Product Code: FCW
• UDI-Device Identifier: 07613327051339
• UDI-Public: 07613327051339
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K082813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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: 0220210000I
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2016
• 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