MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1997-05-01 for OP80 SAGITTAL SAW 0297-088-000 NA manufactured by Stryker Instruments.
[58921]
The saw was very noisy. During surgery, the saw went through the tissue of the heart. Dr. Was able to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1811755-1997-00039 |
| MDR Report Key | 91373 |
| Report Source | 06 |
| Date Received | 1997-05-01 |
| Date of Event | 1997-04-11 |
| Date Facility Aware | 1997-04-11 |
| Date Mfgr Received | 1997-04-14 |
| Device Manufacturer Date | 1986-05-01 |
| Date Added to Maude | 1997-05-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OP80 SAGITTAL SAW |
| Generic Name | SAW |
| Product Code | KFK |
| Date Received | 1997-05-01 |
| Model Number | 0297-088-000 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 11 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 90268 |
| Manufacturer | STRYKER INSTRUMENTS |
| Manufacturer Address | 4100 EAST MILHAM AVE. KALAMAZOO MI 49001 US |
| Baseline Brand Name | OP80 SYSTEM II SAGITTAL SAW |
| Baseline Generic Name | SAW, PNEUMATICALLY POWERED |
| Baseline Model No | 0297-088-000 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Baseline Device Family | PNEUMATIC SAWS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-05-01 |