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

Catalog Number	0220220000I
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2019
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 light source had loss of image.The procedure was completed successfully.
Additional Manufacturer Narrative
The device was not received for investigation at stryker endoscopy because it was repaired locally in stryker united kingdom; therefore the reported failure cannot be confirmed.The complaint will be closed without a detailed investigation report and based on probable root cause.In the event that the device is received, the complaint will be reopened, a full evaluation will be conducted, and the investigation will be updated with the new results.The technical service report is attached (see comm log), and indicates: unit has passed a basic function test/ soak - test but unable to complete qip as the test - equipment is currently out of use.Probable root cause: - front panel damaged / out of spec - power button rod damaged.The product was not returned for investigation therefore the reported failure mode was not confirmed.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the light source had loss of image.The procedure was completed successfully.

• Brand Name: PKG, PRECISION LED LIGHT SOURCE - INTERNATIONAL KIT
• Common Device Name: LIGHT SOURCE, FIBEROPTIC, ROUTINE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8478957
• Report Number: 0002936485-2019-00133
• Device Sequence Number: 942007
• Product Code: FCW
• UDI-Device Identifier: 07613327051322
• UDI-Public: 07613327051322
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2019

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: 0220220000I
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/08/2019
• Supplement Date Received by Manufacturer: 03/08/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 07/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1