ELECTROSURGICAL UNIT/FOOT PEDAL FORCE 4/E6008 N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-16 for ELECTROSURGICAL UNIT/FOOT PEDAL FORCE 4/E6008 N/A manufactured by Valleylab.

Event Text Entries

[18552182] The foot pedal of the electrosurgical device stuck during surgery and caused injury to the patientdevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-aug-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6269
• MDR Report Key: 6269
• Date Received: 1993-08-16
• Date of Report: 1993-07-09
• Date of Event: 1993-07-07
• Date Facility Aware: 1993-07-07
• Report Date: 1993-07-09
• Date Reported to FDA: 1993-07-09
• Date Reported to Mfgr: 1993-07-09
• Date Added to Maude: 1993-08-25
• 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/FOOT PEDAL
• Generic Name: ELECTROSURGICAL GENERATOR/FOOT PEDAL
• Product Code: FAR
• Date Received: 1993-08-16
• Model Number: FORCE 4/E6008
• Catalog Number: N/A
• Lot Number: N/A
• ID Number: N/A
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-APR-86
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 5958
• Manufacturer: VALLEYLAB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-08-16