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

Model Number	0220210000
Medical Device Problem Codes	No Display/Image (1183); Output Problem (3005)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
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.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: image loss.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 failure mode will be monitored for future reoccurrence.H3 other text : 81.
Event or Problem Description
It was reported that there was loss of light.

• 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; 5900 optical court; san jose CA 95138
• Manufacturer Contact: hannah stalnaker ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 12740891
• Report Number: 0002936485-2021-00595
• Device Sequence Number: 11766797
• Product Code: FCW
• UDI-Device Identifier: 07613327051339
• UDI-Public: 07613327051339
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K082813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2021

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 Model Number: 0220210000
• Device Catalogue Number: 0220210000I
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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