MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-10-04 for HALL SURGICAL UNKNOWN 5044-02 manufactured by Zimmer, Inc..
[4585]
While operating oscillating saw for open heart surgery, aorta was lacerated by saw. This was patient's second open heart surgery. It was felt that adhesions which formed after first surgery case caused aorta to be adhered to sternum contributing to the event. Device not labeled for single use. Patient medical status prior to event: fair condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced:. Service provided by: invalid data. Service records not available. 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: none or unknown. Conclusion: there was no device failure. Certainty of device as cause of or contributor to event: yes. Corrective actions: none or unknown. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6723 |
| MDR Report Key | 6723 |
| Date Received | 1993-10-04 |
| Date of Report | 1993-04-20 |
| Date of Event | 1993-04-09 |
| Date Facility Aware | 1993-04-09 |
| Report Date | 1993-04-20 |
| Date Reported to Mfgr | 1993-04-20 |
| Date Added to Maude | 1993-10-13 |
| 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 | HALL SURGICAL |
| Generic Name | OSCILLATING SAW |
| Product Code | HSO |
| Date Received | 1993-10-04 |
| Model Number | UNKNOWN |
| Catalog Number | 5044-02 |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 6406 |
| Manufacturer | ZIMMER, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-10-04 |