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 Number9836
MDR Report Key9836
Date Received1993-08-02
Date of Report1993-07-23
Report Date1993-07-23
Date Added to Maude1995-01-31
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameELECTRODE, ELECTROSURGICAL, ACTIVE, HAND-CONTROLLED
Product CodeHQQ
Date Received1993-08-02
Model NumberE2502
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key9488
ManufacturerVALLEY LAB, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. No Informationnvalid Deathata 1993-08-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.