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	04/30/2018
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 was smoking; there was no associated procedure.
Additional Manufacturer Narrative
Alleged failure: smoking when plugged in cib tom biomedpo#temp.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The issue was not verified.It is advised to replace the control board and ballast.The product was returned for investigation and the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the light source was smoking; there was no associated procedure.

• 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: 7539403
• Report Number: 0002936485-2018-00456
• Device Sequence Number: 1861224
• Product Code: FCW
• UDI-Device Identifier: 07613327051360
• UDI-Public: 07613327051360
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K961971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

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: Other
• Device Catalogue Number: 0220200000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1