SOLID STATE ELECTORSUGERY UNIT SSE 2L

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-16 for SOLID STATE ELECTORSUGERY UNIT SSE 2L manufactured by Valley Lab.

Event Text Entries

[1562] Electro-surgery unit was being used during an endometrial ablation. When the grounding pad was removed from the patient's right thigh a burn was noted. The burn to the right thigh was directly under the grounding pad and approximately 1/4 inch wide and 1 1/2 inches long. After speaking with the doctors and nurses who were in the room during the procedure it was discovered that the grounding pad had partially peeled off before the procedure began and was replaced by the circulating nurse at the time. 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: 4476
• MDR Report Key: 4476
• Date Received: 1993-02-16
• Date of Event: 1992-10-27
• Date Added to Maude: 1993-05-25
• 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: SOLID STATE ELECTORSUGERY UNIT
• Product Code: FAR
• Date Received: 1993-02-16
• Model Number: SSE 2L
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 4196
• Manufacturer: VALLEY LAB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1993-02-16