LAPAROSCOPIC LIGHT CORD *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-08-04 for LAPAROSCOPIC LIGHT CORD * manufactured by Karl Storz Endoscopy-america, Inc..

Event Text Entries

[17019151] The storz laparoscopic light cord broke halfway through the fibers and began to burn a hole in the sterile drapes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1114343
• MDR Report Key: 1114343
• Date Received: 2008-08-04
• Date of Report: 2008-08-04
• Date of Event: 2008-07-24
• Report Date: 2008-08-04
• Date Reported to FDA: 2008-08-04
• Date Added to Maude: 2008-08-18
• 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
• 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: LAPAROSCOPIC LIGHT CORD
• Generic Name: CABLE, FIBER OPTIC
• Product Code: FFZ
• Date Received: 2008-08-04
• 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: 1099578
• Manufacturer: KARL STORZ ENDOSCOPY-AMERICA, INC.
• Manufacturer Address: 600 CORPORATE POINTE CULVER CITY CA 902307600 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2008-08-04