FORCE 2 CAUTERY

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-29 for FORCE 2 CAUTERY manufactured by Valleylab.

Event Text Entries

[17805645] Cautery pencil was activated while laying on the susrsgical field and burned patient's left upper arm causing third degree burn. Ice was applied and dressing with neosporin and then a plastic surgeon was consulted. Patient to be taken to surgery 9/25/92 for excision of burned area and primary closure. The volume control was on low as per routine, and there was also noise from suctioning, the trimedyne yag laser, and the anesthesia ventilator system. Corrective action: currently evaluating products tohold or protect cauterydevice not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-92. 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, visual examination, other. Results of evaluation: misapplication of device, environmental factors. Conclusion: there was no device failure, user error contributed to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2805
• MDR Report Key: 2805
• Date Received: 1993-01-29
• Date of Report: 1992-09-25
• Date of Event: 1992-09-18
• Date Facility Aware: 1992-09-18
• Report Date: 1992-09-25
• Date Reported to FDA: 1992-09-25
• Date Reported to Mfgr: 1992-09-25
• Date Added to Maude: 1993-03-30
• 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: FORCE 2 CAUTERY
• Generic Name: ELECTROSURGICAL CAUTERY
• Product Code: HQR
• Date Received: 1993-01-29
• ID Number: SURGERY #26
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-JUN-89
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 2631
• Manufacturer: VALLEYLAB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-01-29