MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-18 for V. MUELLER RHOTON RETRACTOR NL3785-16 manufactured by Carefusion 2200, Inc.
[80313629]
Patient Sequence No: 1, Text Type: N, H10
[80313630]
A 2mm right angle rhoton dissector ball micro tip broke off onto the surgical field. All three methods were used (c-arm, o-arm and microscope) to rule out if a metallic foreign body item was on the surgical field or retained in the patient. All scans were read and reported to the surgeon by the radiologist, stating nothing was retained in the patient's body. Risk management was called and the instrumentation that was broken was sent off. The broken piece could not be found on field or inside patient. It is believed it was removed by the suction device during wound irrigation. No foreign item was retained in the patient per radiologist. Minor injury to patient was additional radiation required to try to find the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6720929 |
| MDR Report Key | 6720929 |
| Date Received | 2017-07-18 |
| Date of Report | 2017-07-13 |
| Date of Event | 2017-07-11 |
| Report Date | 2017-07-12 |
| Date Reported to FDA | 2017-07-12 |
| Date Reported to Mfgr | 2017-07-12 |
| Date Added to Maude | 2017-07-18 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V. MUELLER RHOTON RETRACTOR |
| Generic Name | RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY |
| Product Code | GZT |
| Date Received | 2017-07-18 |
| Model Number | NL3785-16 |
| Catalog Number | NL3785-16 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION 2200, INC |
| Manufacturer Address | 5 SUNNEN DR. SAINT LOUIS MO 63143 US 63143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-18 |