MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES 600-290 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-03-19 for MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES 600-290 * manufactured by Bowa Electronic Zubehor Fur Elektrochiru.

Event Text Entries

[354368] The device was being used during a surgical procedure. The cord split during use in the o. R. The cord "popped" apart with sparks and smoke at the cautery end of the cord. There was no indication of ensuing fire or injury to staff or pt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2430952-2004-00008
• MDR Report Key: 516782
• Date Received: 2004-03-19
• Date of Report: 2004-03-19
• Date Facility Aware: 2004-02-19
• Report Date: 2004-03-19
• Date Reported to FDA: 2004-03-19
• Date Reported to Mfgr: 2004-03-19
• Date Added to Maude: 2004-03-23
• 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
• 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: MONOPOLAR CABLE, ELECTROSURGICAL ACCESSORIES
• Generic Name: ENDOSCOPIC INSTRUMENT
• Product Code: FFZ
• Date Received: 2004-03-19
• Model Number: 600-290
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 505817
• Manufacturer: BOWA ELECTRONIC ZUBEHOR FUR ELEKTROCHIRU
• Manufacturer Address: * GOMARINGEN GM

Patients

Patient Number	Treatment	Outcome	Date
1	0		2004-03-19