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	01/04/2019
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 there was sparking at the bulb assembly.
Event or Problem Description
It was reported that there was sparking at the bulb assembly.
Additional Manufacturer Narrative
The device was not received for investigation at stryker endoscopy because it was repaired locally in stryker malaysia; 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 communication log), and indicates: "suspected the bulb was not in good a condition.There is a melting negative cable connected to the bulb negative terminal.Troubleshooting was performed by: replaced with the known good xenon bulb replaced with the known good negative cable.The x8000 light source is working in good condition." the reported event involving this failure and device could have been caused by: - "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".In sum, the reported failure could not be confirmed since the device was not received at stryker endoscopy for investigation.The reported failure mode will be monitored for future reoccurrence.

• 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: 8286603
• Report Number: 0002936485-2019-00036
• Device Sequence Number: 19448658
• Product Code: FCW
• UDI-Device Identifier: 07613327051360
• UDI-Public: 07613327051360
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K961971
• 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): 05/31/2019

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: Other
• Device Catalogue Number: 0220200000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/04/2019
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1