MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-17 for MAXILLARY OSTIOUM SEEKER PROBE 70230771 manufactured by Explorent Chirurgische Instrumente Gmbh.
[75510739]
The referenced device was not returned to olympus for evaluation. Therefore, the exact cause of the reported event could not be determined. However, if additional information becomes available or if the device is returned to olympus for evaluation at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[75510740]
Olympus was informed that a part of the device broke and fell into a patient during a (fess) functional endoscopic sinus surgery procedure. The part of the device was not specified. The device fragment was retrieved from the patient. The procedure was completed using the same set of equipment. No patient/user injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00356 |
| MDR Report Key | 6571719 |
| Date Received | 2017-05-17 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-04-12 |
| Date Mfgr Received | 2017-04-18 |
| Date Added to Maude | 2017-05-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MAXILLARY OSTIOUM SEEKER PROBE |
| Generic Name | MAXILLARY OSTIOUM SEEKER PROBE |
| Product Code | KAK |
| Date Received | 2017-05-17 |
| Model Number | 70230771 |
| Catalog Number | 70230771 |
| Lot Number | UNKNOWN |
| ID Number | UDI |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXPLORENT CHIRURGISCHE INSTRUMENTE GMBH |
| Manufacturer Address | GOTENSTRASSE 3 TUTTLINGEN D-78503 GM D-78503 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-17 |