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.
[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
| Report Number | 4536 |
| MDR Report Key | 4536 |
| Date Received | 1992-07-09 |
| Date of Report | 1992-02-25 |
| Date of Event | 1992-02-19 |
| Date Facility Aware | 1992-02-19 |
| Report Date | 1992-02-25 |
| Date Reported to FDA | 1992-02-25 |
| Date Reported to Mfgr | 1992-02-20 |
| Date Added to Maude | 1993-05-26 |
| 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 |
| Brand Name | AMSCO |
| Product Code | FSE |
| Date Received | 1992-07-09 |
| Model Number | 1080M |
| Catalog Number | 4007054 |
| Lot Number | N/A |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 4255 |
| Manufacturer | AMERICAN STERILIZER COMPANY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1992-07-09 |