MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE KIT, X8000 LIGHTSOURCE, EUROPE; LIGHT SOURCE, FIBEROPTIC, ROUTINE

Model Number	0220200000
Medical Device Problem Code	Optical Problem (3001)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2022
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
It was reported that there was loss of light.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: displayed e2 error probable root cause: bulb assembly.Ballast.Control board.Ac inlet board.Reed switch.Thermal switch.Ballast connector.Beam sensor.Fuses.Front panel membrane switch.Esst components.Motor assembly.Sidne input.Light post.Inadequate airflow.Improper assembly.Inadequate calibration.Em interference.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: KIT, X8000 LIGHTSOURCE, EUROPE
• 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: 14762423
• Report Number: 0002936485-2022-00375
• Device Sequence Number: 6153090
• Product Code: FCW
• UDI-Device Identifier: 07613327051360
• UDI-Public: 07613327051360
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K961971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2022

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: 0220200000
• Device Catalogue Number: 0220200000E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/31/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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 Age: 32 YR
• Patient Sex: Female