MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1997-12-03 for XPS STRAIGHTSHOT SYSTEM 18-95000 manufactured by Xomed Surgical Products.
[76054]
Patient underwent septal plasty surgery for acute sinusitis using the xomed xps straightshot (tm) powered micro-resector system. A single-use, disposable, the rad 40 (tm) blade was used as an attachment to the system. It was reported that the patient's dura was nicked during the procedure and subsequently patched. It was also reported that the patient expired three days later due to complications leading to increased blood pressure and bleeding. User facility stated there was no issue with xomed equipment and equipment was not taken out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-1997-00003 |
| MDR Report Key | 135990 |
| Report Source | 05,06,07 |
| Date Received | 1997-12-03 |
| Date of Report | 1997-11-18 |
| Date of Event | 1997-09-15 |
| Date Mfgr Received | 1997-11-18 |
| Date Added to Maude | 1997-12-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XPS STRAIGHTSHOT SYSTEM |
| Generic Name | POWERED MICRO-RESECTOR |
| Product Code | KAS |
| Date Received | 1997-12-03 |
| Model Number | XPS STRAIGHTSHOT SYSTEM |
| Catalog Number | 18-95000 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 132849 |
| Manufacturer | XOMED SURGICAL PRODUCTS |
| Manufacturer Address | 6743 SOUTHPOINT DR. NORTH JACKSONVILLE FL 32216 US |
| Baseline Brand Name | XPS STRAIGHTSHOT (TM) SYSTEM |
| Baseline Generic Name | POWERED MICRO-RESECTOR |
| Baseline Model No | XPS STRAIGHTSHO |
| Baseline Catalog No | 18-95000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-12-03 |