FORCE 2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-07-22 for FORCE 2 manufactured by Valleylab Inc..

Event Text Entries

[3732] Patient returned to the emergency room one week after left femoral hernia repair. Patient presented a rectangular lesion on upper right thigh dimensions approximately 47mm x 20mm. Hospital investigating possible involvement of electrosurgical unit dispersive electrode pad. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-mar-92. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated. Results of evaluation: unanticipated adverse reaction - short term. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6753
• MDR Report Key: 6753
• Date Received: 1993-07-22
• Date of Report: 1993-03-16
• Date of Event: 1993-03-05
• Date Facility Aware: 1993-03-12
• Report Date: 1993-03-16
• Date Added to Maude: 1993-10-14
• 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

• Generic Name: ELECTROSURGICAL UNIT
• Product Code: FAR
• Date Received: 1993-07-22
• Model Number: FORCE 2
• ID Number: HOSP ID #38992
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-MAR-90
• Implant Flag: N
• Device Sequence No: 1
• Device Event Key: 6436
• Manufacturer: VALLEYLAB INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-07-22