MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-04 for HERCULES manufactured by Terumo Cardiovascular Systems Corporation.
[177653656]
Hercules retractor found to have broken pieces after removing from chest. Two small pieces of metal found on outside of chest. No pieces found in patient's chest, confirmed via x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9665567 |
| MDR Report Key | 9665567 |
| Date Received | 2020-02-04 |
| Date of Report | 2019-11-22 |
| Date of Event | 2019-11-11 |
| Report Date | 2019-11-22 |
| Date Reported to FDA | 2019-11-22 |
| Date Reported to Mfgr | 2020-02-04 |
| Date Added to Maude | 2020-02-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HERCULES |
| Generic Name | INSTRUMENTS, SURGICAL, CARDIOVASCULAR |
| Product Code | DWS |
| Date Received | 2020-02-04 |
| Returned To Mfg | 2019-11-18 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
| Manufacturer Address | 125 BLUE BALL RD ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |