VARITRONICS NEVYAS 1899K 1243

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-30 for VARITRONICS NEVYAS 1899K 1243 manufactured by Varitronics.

Event Text Entries

[124952] During an eyelid operation: the electrosurgical output setting was increased from a 10 watt setting to 15 and then to 20 watts in order to obtain a stronger spark to ease the cutting action. When the pencil was activated on the 20 watt setting, a flash was emitted from the tip. The cardboard "nevyas" retractor ignited and spread to the plastic drape. The fire was immediately extinguished by the surgeon. Oxygen was turned off by the anesthesiologist. Burned areas on the pt's face were observed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 146408
• MDR Report Key: 146408
• Date Received: 1998-01-30
• Date of Report: 1997-12-19
• Date of Event: 1997-12-03
• Date Facility Aware: 1997-12-03
• Report Date: 1997-12-19
• Date Reported to Mfgr: 1997-12-19
• Date Added to Maude: 1998-02-02
• 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: VARITRONICS
• Generic Name: DRAPE RETRACTOR
• Product Code: HMT
• Date Received: 1998-01-30
• Model Number: NEVYAS
• Catalog Number: 1899K 1243
• Lot Number: NA
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 142696
• Manufacturer: VARITRONICS
• Manufacturer Address: 620 PARKWAY BROOMALL PA 19008 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1998-01-30