MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-25 for FREER ELEVATOR N/A 18-1968 manufactured by Miltex.
[1645]
Other devices used: dyonics arthroscopeinstrument experienced a fitgue fracture and tip broke off in the incision area. The tip was removed & instrument was removed from the o. R. Room. No further incident noted & no untoward effect to patientdevice not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not 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. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: component failure. Conclusion: device failed just prior to use. Certainty of device as cause of or contributor to event: yes. Corrective actions: no data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4594 |
| MDR Report Key | 4594 |
| Date Received | 1993-02-25 |
| Date of Report | 1993-01-15 |
| Date of Event | 1993-01-06 |
| Date Facility Aware | 1993-01-06 |
| Report Date | 1993-01-15 |
| Date Reported to FDA | 1993-01-15 |
| Date Reported to Mfgr | 1993-01-07 |
| Date Added to Maude | 1993-05-28 |
| 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 | FREER ELEVATOR |
| Product Code | GEG |
| Date Received | 1993-02-25 |
| Model Number | N/A |
| Catalog Number | 18-1968 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 4313 |
| Manufacturer | MILTEX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1993-02-25 |