ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND-CONTROLLED E2502

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-08-02 for ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND-CONTROLLED E2502 manufactured by Valley Lab, Inc..

Event Text Entries

[7990] While using the pencil for cauterization, the pencil continued to work even after it was turned off. The switch appeared to be stuck. The pencil cord had to be cut in order to remove the pencil from the sterile field. The patient sustained a burn which had to be excised and closed. 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: 9836
• MDR Report Key: 9836
• Date Received: 1993-08-02
• Date of Report: 1993-07-23
• Report Date: 1993-07-23
• Date Added to Maude: 1995-01-31
• 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: ELECTRODE, ELECTROSURGICAL, ACTIVE, HAND-CONTROLLED
• Product Code: HQQ
• Date Received: 1993-08-02
• Model Number: E2502
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 9488
• Manufacturer: VALLEY LAB, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. No Informationnvalid Deathata	1993-08-02