MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-13 for PILLING FAVALORO-MORSE STERNAL RETRACTOR * 341163 manufactured by Teleflex Medical.
[5353907]
The physician placed the swanson retractor into the chest cavity. He opened the retractor to gain access to the field. As he spread the blades, the handle broke. They were unable to get the retractor out at the time due to the cannulas being in the heart. When the physician was finished with the surgery the retractor was removed. All of the pieces were intact and accounted for. A chest x-ray was taken before the patient left the room to confirm all pieces were retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4530397 |
| MDR Report Key | 4530397 |
| Date Received | 2015-02-13 |
| Date of Report | 2015-02-13 |
| Date of Event | 2015-01-23 |
| Report Date | 2015-02-13 |
| Date Reported to FDA | 2015-02-13 |
| Date Reported to Mfgr | 2015-02-20 |
| Date Added to Maude | 2015-02-20 |
| 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 |
| 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 | PILLING FAVALORO-MORSE STERNAL RETRACTOR |
| Generic Name | RETRACTOR |
| Product Code | EIG |
| Date Received | 2015-02-13 |
| Model Number | * |
| Catalog Number | 341163 |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | 2917 WECK DRIVE RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-13 | |
| 2 | 0 | 2015-02-13 |