MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-03-01 for QUADCUT STRAIGHTSHOT * 1884380HR manufactured by Medtronic Xomed, Inc.
[15861675]
Metal portion broke during the procedure under normal use. Question if it may have been cracked prior to use. No patient harm or change in plan of care. No adverse effects on patient or blood loss. Procedure completed as planned. ======================manufacturer response for microdebriding rotating blade, quadcut blade, 4. 3 mm (per site reporter). ======================we plan to return to them for evaluation. What was the original intended procedure? Left and right sphenoethmoidectomy with removal of polyps; left and right maxillary antrostomy with removal of polyps for chronic polypoid rhinosinusitis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2994002 |
| MDR Report Key | 2994002 |
| Date Received | 2013-03-01 |
| Date of Report | 2013-03-01 |
| Date of Event | 2013-02-04 |
| Report Date | 2013-03-01 |
| Date Reported to FDA | 2013-03-01 |
| Date Reported to Mfgr | 2013-03-08 |
| Date Added to Maude | 2013-03-08 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUADCUT STRAIGHTSHOT |
| Generic Name | BLADE, BURR |
| Product Code | HTT |
| Date Received | 2013-03-01 |
| Model Number | * |
| Catalog Number | 1884380HR |
| Lot Number | 0206266062 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-01 |