MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-31 for EWEND SUCTION RING CURETTE N090D5.0-160 manufactured by Synergetics, Inc. (n/k/a Bausch & Lomb).
[98855937]
While pt was undergoing a transsphenoidal hypophysectomy for a pituitary tumor, the ring curette instrument broke apart in the pt's nasal cavity/brain tissue. The end of the curette separated from the handle at the distal attachment. The instrument was removed, but the pt sustained a cerebrovascular event. Pt was intubated with poor prognosis until care withdrawn.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5074991 |
| MDR Report Key | 7233663 |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-30 |
| Date of Event | 2018-01-17 |
| Date Added to Maude | 2018-02-01 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | ATTORNEY |
| 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 | 0 |
| Brand Name | EWEND SUCTION RING CURETTE |
| Generic Name | SURGICAL INSTRUMENT |
| Product Code | HTF |
| Date Received | 2018-01-31 |
| Model Number | N090D5.0-160 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNERGETICS, INC. (N/K/A BAUSCH & LOMB) |
| Manufacturer Address | ST. LOUIS MO 63166 US 63166 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-01-31 |