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

Catalog Number	0220200000
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
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 the product lost image.The procedure was completed successfully.
Additional Manufacturer Narrative
The product was not received for investigation at stryker endoscopy because it was evaluated at stryker bejing.The reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.The technical service report is attached (see communication log), and indicates: - symptom - light source start up failure.Diagnosis & service performed: replace bulb module.The reported event involving this failure and product could have been caused by: - malfunctioning control board - malfunctioning display board - improper assembly - fans not running use error.
Event or Problem Description
It was reported that the product lost image.The procedure was completed successfully.

• Brand Name: PKG, X8000 LIGHT SOURCE
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8578207
• Report Number: 0002936485-2019-00187
• Device Sequence Number: 13905613
• Product Code: FCW
• UDI-Device Identifier: 07613327051360
• UDI-Public: 07613327051360
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: 0220200000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1