ELECTROSURGICAL UNIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-09-02 for ELECTROSURGICAL UNIT manufactured by Valleylab.

Event Text Entries

[14673] There was a reported malfunction of a electrosurgical unit which caused injury to a patient's prostate and shocked the device operator. The patient required surgical intervention to correct the damage caused when the unit allegedly spontaneously activated. There was some frayed wiring on the foot switch but it could not be determined if this was the cause. The unit was immediately taken out of service. 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: 20887
• MDR Report Key: 20887
• Date Received: 1993-09-02
• Date of Report: 1993-07-27
• Date of Event: 1993-01-09
• Report Date: 1993-07-27
• Date Added to Maude: 1995-03-20
• 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: ELECTROSURGICAL UNIT
• Product Code: FAR
• Date Received: 1993-09-02
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 20786
• Manufacturer: VALLEYLAB

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-09-02