MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-28 for FK-WO TORS LARYNGO PHARYNGOSCOPE RETRACTOR WT645033 645000 manufactured by Olympus Winter & Ibe Gmbh.
[68823297]
The referenced device was not returned to olympus for evaluation. The exact cause of the reported event could not be conclusively determined. However, if additional information becomes available or if the device is returned for evaluation, this report will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[68823298]
The user facility reported the device tongue blade snapped and fell during a diagnostic direct laryngoscopy. The physician was attempting to open the device wider when a tongue blade broke off and fell, however, the blade did not fall into the patient. The intended procedure was completed using a different device. The device was inspected prior to procedure with no abnormalities observed. The tongue blade was retrieved and will be returned with the device for evaluation
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00136 |
| MDR Report Key | 6366656 |
| Date Received | 2017-02-28 |
| Date of Report | 2018-03-27 |
| Date of Event | 2017-02-03 |
| Date Mfgr Received | 2018-03-05 |
| Device Manufacturer Date | 2010-04-10 |
| Date Added to Maude | 2017-02-28 |
| 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 | FK-WO TORS LARYNGO PHARYNGOSCOPE RETRACTOR |
| Generic Name | LARYNGO PHARYNGOSCOPE RETRACTOR |
| Product Code | KAL |
| Date Received | 2017-02-28 |
| Returned To Mfg | 2018-01-25 |
| Model Number | WT645033 |
| Catalog Number | 645000 |
| Lot Number | 04-10 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG, HAMBURG US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-28 |