AMSCO 1080M 4007054

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-09 for AMSCO 1080M 4007054 manufactured by American Sterilizer Company.

Event Text Entries

[19961636] While positioning table in reverse trandelenberg crank would not turn at surgeons insistence crank was forced causing a noise and the table to jump. Nurse's toe was fractured during the incidentdevice 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-dec-91. Service provided by: manufacturer. 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, mechanical tests performed, performance tests performed, visual examination. Results of evaluation: incorrect technique/procedure. Conclusion: device evaluated and alleged failure could not be duplicated, user error caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device temporarily removed from service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4536
MDR Report Key4536
Date Received1992-07-09
Date of Report1992-02-25
Date of Event1992-02-19
Date Facility Aware1992-02-19
Report Date1992-02-25
Date Reported to FDA1992-02-25
Date Reported to Mfgr1992-02-20
Date Added to Maude1993-05-26
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 NameAMSCO
Product CodeFSE
Date Received1992-07-09
Model Number1080M
Catalog Number4007054
Lot NumberN/A
ID NumberN/A
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagN
Device Sequence No1
Device Event Key4255
ManufacturerAMERICAN STERILIZER COMPANY


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1992-07-09

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