ELECTROSURGICAL UNIT FORCE 2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-10 for ELECTROSURGICAL UNIT FORCE 2 manufactured by Valleylab Inc..

Event Text Entries

[20889020] Anesthesia machine - narkomed 2a - north american drager; physiological monitor - 404-1 - semines medical............. 35. Whileusing forceps dr. Requested electrosurgical unit be increased to coag 99. Before nurse could swith unit to low coag mode setting 99, dr. Began using unit and received a shock from the forceps to his right middle finger. Dr. Required no treatment and the burn has since healed. No injury or burns to patient occureddevice not labeled for single use. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-aug-91. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, electrical tests performed, performance tests performed, visual examination. Results of evaluation: other. Conclusion: user error contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: user education provided. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4195
• MDR Report Key: 4195
• Date Received: 1992-07-10
• Date of Report: 1992-01-31
• Date of Event: 1991-12-30
• Date Facility Aware: 1991-12-30
• Report Date: 1992-01-31
• Date Reported to Mfgr: 1992-01-31
• Date Added to Maude: 1993-05-17
• 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: 0
• Initial Report to FDA: 0
• 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: ELECTROSURGICAL UNIT
• Generic Name: ELECTROSURGICAL UNIT
• Product Code: FAR
• Date Received: 1992-07-10
• Model Number: FORCE 2
• ID Number: Y 19020
• Device Expiration Date: 1988-05-01
• Operator: OTHER
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 3928
• Manufacturer: VALLEYLAB INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1992-07-10