MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. KARL STORZ XENON 300 LIGHT SOURCE; IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE

Model Number 20133120

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Date 05/08/2014

Event Type  No Answer Provided  

Event Description

Physician was performing a video assisted laparoscopic thoracoscopy in or.When he was attaching the equipment, the light source went out.Another video tower had to be brought in.

• Brand Name: KARL STORZ XENON 300 LIGHT SOURCE
• Type of Device: IMAGE, ILLUMINATION, FIBEROPTIC, FOR ENDOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245 501
• MDR Report Key: 4043762
• MDR Text Key: 17296762
• Report Number: 4043762
• Device Sequence Number: 1
• Product Code: FFS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/23/2014

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?: *
• Device Operator: Physician
• Device Model Number: 20133120
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER
• Patient Age: 17 YR
• Patient Weight: 43