ELECTO-SURGICAL UNIT FORCE 2-20, PC 21287

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-23 for ELECTO-SURGICAL UNIT FORCE 2-20, PC 21287 manufactured by Valley Lab.

Event Text Entries

[7884] Following smooth halothan induction, patient underwent myringtomy tube placement under mask anesthesia. This was followed by intubation in preparation for tonisllectomy. Surgeon packed throat. After initiation of electrocautery an airway fire ensued. An evacuation of the fire was performed immediately. Patient vital signs were stable following incident. Evaluation of the incident & equip. Was performed by ecri with all equip found to be working properly. Invalid data - regarding single use labeling of device. Patient medical status prior to event: invalid data. Invalid data - regarding multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Invalid data - regarding whether event presents imminent hazard. Invalid data - whether device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: invalid data. Results of evaluation: invalid data. Conclusion: invalid data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 10031
• MDR Report Key: 10031
• Date Received: 1993-07-23
• Date of Report: 1993-07-06
• Report Date: 1993-07-06
• Date Added to Maude: 1995-03-17
• 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: ELECTO-SURGICAL UNIT
• Product Code: FAR
• Date Received: 1993-07-23
• Model Number: FORCE 2-20, PC 21287
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 9683
• Manufacturer: VALLEY LAB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-07-23