MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-05-10 for GUIDEWIRE,0.035 BENTSON,5-UP 10BX manufactured by Lake Region Manufacturing.
[144853151]
The referenced device was returned to olympus but the investigation is ongoing. The device will be forwarded to the oem for further investigation. If additional information becomes available, this report will be supplemented accordingly. As a preventive measure, the instruction manual provides warning which states, the tips of some metal instruments may cause the coating material on the guidewire to be scraped off under conditions of sharp bending or kinking. If this occurs, it is recommended that any fragments of the outer coating material be removed. While advancing or withdrawing any coated guidewire, avoid sharply bending or kinking the portion of the guidewire that extends beyond the instrument. Do not apply excessive force to advance or withdraw the guidewire. Doing so may result in complications. If resistance is encountered, determine the cause and take remedial action before continuing.
Patient Sequence No: 1, Text Type: N, H10
[144853152]
Olympus was informed that during the middle of a therapeutic ureteroscopy (with laser stone and stent placement) procedure, the device was advanced and curled into the patient? S kidney when the doctor observed about 6-8cm of the distal end portion of the device was broken off completely. The doctor successfully removed the device fragment from the patient utilizing a wolf ureteral grasper without harm. The intended procedure was completed with a second similar device. Additionally, there was no unexpected bleeding to the patient and the procedure was prolonged by ten minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00834 |
| MDR Report Key | 8602160 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-05-10 |
| Date of Report | 2019-07-15 |
| Date of Event | 2019-04-19 |
| Date Mfgr Received | 2019-06-17 |
| Date Added to Maude | 2019-05-10 |
| 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 | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GUIDEWIRE,0.035 BENTSON,5-UP |
| Generic Name | GUIDEWIRE |
| Product Code | EYA |
| Date Received | 2019-05-10 |
| Returned To Mfg | 2019-04-29 |
| Model Number | 10BX |
| Lot Number | 11029251 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LAKE REGION MANUFACTURING |
| Manufacturer Address | 340 LAKE HAZELTINE DRIVE CHASKA MN 55318 US 55318 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |