MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-12 for FLYTE HOOD W/PEELAWAY 0408800100 manufactured by Stryker Instruments Kalamazoo.
[21283803]
It was reported that there are small white fibers blowing around outside the helmet and there is concern that the fibers are being inhaled by the surgeon and possibly compromising the sterile field. The surgeon has been using eye drops as a result of this, but there have been no allegations of adverse consequences for the patient.
Patient Sequence No: 1, Text Type: D, B5
[21480154]
The device will not be returned to the manufacturer for investigation. The quality investigation is ongoing. A follow up report will be filed when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1811755-2011-00096 |
| MDR Report Key | 1966589 |
| Report Source | 07 |
| Date Received | 2011-01-12 |
| Date of Report | 2010-12-16 |
| Date of Event | 2010-12-16 |
| Date Mfgr Received | 2010-12-16 |
| Device Manufacturer Date | 2010-04-12 |
| Date Added to Maude | 2011-06-22 |
| 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 | 0 |
| Manufacturer Contact | CHRISTINA MCKEE |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVE. |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLYTE HOOD W/PEELAWAY |
| Generic Name | HOOD, SURGICAL |
| Product Code | FXY |
| Date Received | 2011-01-12 |
| Catalog Number | 0408800100 |
| Lot Number | 1010262 |
| Device Expiration Date | 2013-04-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS KALAMAZOO |
| Manufacturer Address | KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-12 |