SYSTEM 5000 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-13 for SYSTEM 5000 UNKNOWN manufactured by Ems/davol.

Event Text Entries

[1588] 64 year old female, in satisfactory condition, was undergoing surgery for removal of a liver tumor. After the surgery was in progress, the primary surgeon requested a second bovie unit be set up for the surgeon assisting him. The rn placed the second bovie under the patient's right thigh. The patient was already drapped and visability was poor. The nurse was wearing gloves, per univeral precautions aand did not feel the ted stocking on the patient's leg. The bovie pad was partially placed over the top of the stocking. At the end of the surgical procedure a 10 cm burn was found on the right thigh. The area was exccised and sutured closed by the surgeondevice 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, electrical tests performed, performance tests performed. Results of evaluation: design - inadequate, misapplication of device. Conclusion: user error caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service, user education provided, other. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3980
MDR Report Key3980
Date Received1992-07-13
Date of Event1992-06-23
Date Facility Aware1992-06-23
Date Reported to Mfgr1992-06-26
Date Added to Maude1993-05-10
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 NameSYSTEM 5000
Generic NameBOVIE
Product CodeHAM
Date Received1992-07-13
Model Number5000
Catalog NumberUNKNOWN
ID Number70100053 (OURS)
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key3714
ManufacturerEMS/DAVOL


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-07-13

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