MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-12-18 for HALL STERUM * 5059-005 manufactured by Conmed Corporation.
[3059286]
During the opening, the pneumatic powered sternum saw had a connector hose rupture that resulted in no injuries, but re-prepping of the chest area for sterility. Another pneumatic powered sternum saw was obtained, and median sternotomy completed without further incidence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2900839 |
| MDR Report Key | 2900839 |
| Date Received | 2012-12-18 |
| Date of Report | 2012-12-18 |
| Date of Event | 2012-04-02 |
| Report Date | 2012-12-18 |
| Date Reported to FDA | 2012-12-18 |
| Date Added to Maude | 2013-01-08 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HALL STERUM |
| Generic Name | HANDPIECE, SAW, PNEUMATIC |
| Product Code | KFK |
| Date Received | 2012-12-18 |
| Model Number | * |
| Catalog Number | 5059-005 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 11311 CONCEPT BOULEVARD LARGO FL 33773 US 33773 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-18 |