SSSSE3B-11AF/E8003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-23 for SSSSE3B-11AF/E8003 manufactured by Valley Labs, Inc..

Event Text Entries

[6128] Electrosurgical unit alarm sounded when used without grounding pad during surgery. Staff thought it was not necessary to use grounding pad when using machine in bipolar mode. Biomed engineer checked machine and found nothing wrong with unit. According to manual, the unit should be used with grounding pad when in bipolar mode, & thus the unit reacted properly. Out come: user error. No injury to pt. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. Date last serviced: 01-apr-94. 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, performance tests performed. Results of evaluation: none or unknown, none or unknown, alarm failure. Conclusion: user error caused event. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: inserviced by biomedical engineering dept. Staff. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8965
• MDR Report Key: 8965
• Date Received: 1994-09-23
• Date of Report: 1994-08-12
• Date of Event: 1994-08-02
• Date Facility Aware: 1994-08-02
• Report Date: 1994-08-12
• Date Reported to FDA: 1994-08-12
• Date Added to Maude: 1994-11-02
• 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: 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

• Generic Name: ELECTROSURGICAL CABINET
• Product Code: FAR
• Date Received: 1994-09-23
• Model Number: SSSSE3B-11AF/E8003
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 8625
• Manufacturer: VALLEY LABS, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1994-09-23