STORZ *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-27 for STORZ * manufactured by Karl Storz Endoscopy-america, Inc..

Event Text Entries

[471113] The lights went out on the ent microscope while doctor was doing an ear procedure. Biomedical engineering was called and another ent microscope was substituted. Biomed has archived the light source because we can not purchase the failed part from the manufacturer, or a third party. The light source was replaced with another older light source. It seems to be an acceptable temporary solution until the entire microscope and light source are replaced with newer technology.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 719666
• MDR Report Key: 719666
• Date Received: 2006-02-27
• Date of Report: 2006-02-27
• Date of Event: 2006-01-18
• Report Date: 2006-02-27
• Date Reported to FDA: 2006-02-27
• Date Added to Maude: 2006-05-30
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STORZ
• Generic Name: ENT MICROSCOPE, LIGHT
• Product Code: FSW
• Date Received: 2006-02-27
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 708735
• Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
• Manufacturer Address: 600 CORPORATE POINTE CULVER CITY CA 902307600 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-02-27