MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2015-03-16 for FAVALORO-MORSE STERN RET SHORT 341163 manufactured by Teleflex Medical.
[5653731]
Alleged event: 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 pt left the room to confirm all pieces were retrieved.
Patient Sequence No: 1, Text Type: D, B5
[13087959]
Qn # (b)(4). The device sample has not been returned to the mfr for investigation at the time of this report. The mfr will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2015-00126 |
| MDR Report Key | 4611491 |
| Report Source | 00,06 |
| Date Received | 2015-03-16 |
| Date of Report | 2015-03-01 |
| Date of Event | 2015-01-23 |
| Date Mfgr Received | 2015-03-01 |
| Date Added to Maude | 2015-04-29 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EFFIE JEFFERSON, RA |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FAVALORO-MORSE STERN RET SHORT |
| Generic Name | RETRACTOR |
| Product Code | EIG |
| Date Received | 2015-03-16 |
| Catalog Number | 341163 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-16 |