KARL STORZ 495NCS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-11 for KARL STORZ 495NCS manufactured by Karl Storz Endovision.

Event Text Entries

[594802] Doctor was starting a lap chole procedure; the light cable was plugged into an active light source and laid on the pt drape with no scope attached. A nurse noticed smoke rising from the drape. They moved light cable and drape and found that the pt had rec'd a small burn on the chin approximately 4. 8 mm in size. Patient was treated with saline, bacitracin ointment and a bandaid was put on. No further treatment was scheduled or planned. Hospital stated that there was no malfunction of light cable.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2020550-2007-00001
• MDR Report Key: 812751
• Date Received: 2007-01-11
• Date of Report: 2007-01-10
• Date of Event: 2006-12-08
• Date Facility Aware: 2006-12-11
• Report Date: 2007-01-11
• Date Reported to FDA: 2007-01-11
• Date Reported to Mfgr: 2007-01-11
• Date Added to Maude: 2007-02-07
• Event Key: 0
• Report Source Code: Distributor report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• 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: KARL STORZ
• Generic Name: LIGHT CABLE
• Product Code: FFZ
• Date Received: 2007-01-11
• Model Number: 495NCS
• Catalog Number: 495NCS
• Lot Number: KF
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 2 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 800236
• Manufacturer: KARL STORZ ENDOVISION
• Manufacturer Address: * CHARLTON MA * US
• Baseline Brand Name: KARL STORZ
• Baseline Generic Name: LIGHT CABLE
• Baseline Model No: 495NCS
• Baseline Catalog No: 495NCS
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2007-01-11