MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-10-01 for HANDPIECE HYDRODEBRIDER FRONTAL 1921002 manufactured by Medtronic Xomed, Inc..
[1772593]
On (b)(6)2010, medtronic was notified of an event. On 09/03/2010, medtronic became aware that a reportable event occurred. The medtronic sales rep reported that the surgeon was using the frontal handpiece and noticed that no fluid was being returned from the frontal sinuses, as it was actually going into the area surrounding the pt's eye. Pt temporarily flat-lined, and they noticed that the pt's orbit had filled with fluid. The pt's eye was swollen, pt's vision is fine.
Patient Sequence No: 1, Text Type: D, B5
[8686364]
A review of the performance of the device was not possible as the device was not returned for analysis. There is no inventory remaining of the reported lot number 69165100. The device history record was reviewed, and it does not indicate any abnormalities with the production of this lot. Procedure: standard fess for polyps. Frontal recess opened and polyps removed. Thick material in sinus, intended to flush. Visualized frontal irrigator going into the frontal recess. Began irrigation, did not see fluid flashback, stopped irrigation. Notified by anesthesia that pt was asystolic. Looked down and noticed profound soft tissue swelling around that eye and chemosis. Doctor removed irrigator and instruments; spontaneous return of heart activity and completed the surgery. Upon waking, no visual problems. Pt observed then sent home. Swelling resolved within 48hrs. Pt is doing well.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2010-00050 |
| MDR Report Key | 1869359 |
| Report Source | 05,07 |
| Date Received | 2010-10-01 |
| Date of Report | 2010-08-27 |
| Date of Event | 2010-08-27 |
| Date Mfgr Received | 2010-09-03 |
| Device Manufacturer Date | 2010-08-01 |
| Date Added to Maude | 2010-10-20 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DR. NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HANDPIECE HYDRODEBRIDER FRONTAL |
| Generic Name | 77KMA |
| Product Code | KMA |
| Date Received | 2010-10-01 |
| Model Number | 1921002 |
| Catalog Number | 1921002 |
| Lot Number | 69165100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-10-01 |