MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-08 for ANGLED, ARTICULATING, TRIANGULAR RETRACTOR 89-6112 manufactured by Carefusion.
[15937794]
During surgery, (b)(6) 2013, a laparoscopic liver retractor malfunctioned. The decision was to convert to an open operation to ensure that all pieces of this liver retractor were accounted for. Xrays were taken at the end of the case, read as negative. However, after an mri in (b)(6) 2014 showed an object. A piece of the retractor was removed from the sq tissue (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037211 |
| MDR Report Key | 3929644 |
| Date Received | 2014-07-08 |
| Date of Report | 2014-07-07 |
| Date of Event | 2014-06-18 |
| Date Added to Maude | 2014-07-14 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGLED, ARTICULATING, TRIANGULAR RETRACTOR |
| Generic Name | LIVER RETRACTOR |
| Product Code | EIG |
| Date Received | 2014-07-08 |
| Model Number | 89-6112 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-07-08 |