LUXTEC * 24-3171

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-01-29 for LUXTEC * 24-3171 manufactured by Integra York Pa Inc..

Event Text Entries

[2555490] Surgeon stated that the luxtec light cord used in conjunction with the rigid short storz scope, spm #510599-1 melted the hub when used on the medtronic 13cm neuroendoscope 2233-005 and two of the medtronic 15. 5 cm neuropens 2120-025. This was done previous to this nurse arriving in the or. Surgeon stated the luxtec cord is what they usually use for these cases but that it was not compatible with the storz light source in the or. Surgeon stated there was no injury to the patient, but the case was prolonged approximately 30-40 min.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2477878
• MDR Report Key: 2477878
• Date Received: 2012-01-29
• Date of Report: 2012-01-29
• Date of Event: 2012-01-03
• Report Date: 2012-01-29
• Date Reported to FDA: 2012-01-29
• Date Added to Maude: 2012-03-05
• 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 Sequence Number: 1

• Brand Name: LUXTEC
• Generic Name: LIGHT SOURCE, FIBER OPTIC
• Product Code: EQH
• Date Received: 2012-01-29
• Model Number: *
• Catalog Number: 24-3171
• Lot Number: 0307
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INTEGRA YORK PA INC.
• Manufacturer Address: 589 DAVIES DR YORK PA 17402 US 17402

Device Sequence Number: 2

• Brand Name: NEUROPEN
• Generic Name: NEUROENDOSCOPE
• Product Code: GWG
• Date Received: 2012-01-29
• Model Number: *
• Catalog Number: 2120-025
• Lot Number: D12639; 2013-08
• ID Number: *
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MEDTRONIC NEUROSURGERY
• Manufacturer Address: 125 CREMONA DR. GOLETA CA 93117 US 93117

Device Sequence Number: 3

• Brand Name: CHANNEL NEUROENDOSCOPE
• Generic Name: CHANNEL NEUROENDOSCOPE, HIGH RESOLUTION
• Product Code: GWG
• Date Received: 2012-01-29
• Model Number: 2233-005
• Catalog Number: 2233-005
• Lot Number: C56933
• ID Number: *
• Device Availability: Y
• Device Age: 1 DY
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: MEDTRONIC NEUROSURGERY
• Manufacturer Address: 125 CREMONA DR. GOLETA CA 93117 US 93117

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-01-29