MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-25 for MEDIASTINOSCOPE, 35?, 160 MM WORKING LENGTH, AUTOCLAVABLE WA52050A manufactured by Olympus Winter & Ibe Gmbh.
[45963476]
No device was returned to olympus for evaluation. The serial# of the mediastinoscope used during the procedure was not provided and the name of the user facility is unknown. The cause of the reported event could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[45963477]
Olympus received a voluntary medwatch report (mw5061743), which reported that during a surgical procedure for lung cancer using mediastinoscope, and video-assisted thoracoscopic lobectomy, the patient had bilateral vocal cord paralysis. This complication necessitated urgent tracheostomy to protect the patient's airway and gastrostomy was used to provide a means for alimentation. It was unknown why both vocal cords were affected. One vocal cord was affected probably due to the tumor extension into the mediastinum. However the contralateral vocal cord was also injured probably during the mediastinoscopy procedure. It was suspected that the mediastinoscope design might contribute to the injury. The anatomy may be distorted sufficiently to allow for inadvertent injury to the recurrent laryngeal nerve which lies in the tracheoesophageal groove during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2016-00459 |
| MDR Report Key | 5680101 |
| Date Received | 2016-05-25 |
| Date of Report | 2016-05-25 |
| Date of Event | 2016-04-13 |
| Date Mfgr Received | 2016-05-06 |
| Date Added to Maude | 2016-05-25 |
| 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 | MR DONNY SHAPIRO |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-516 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDIASTINOSCOPE, 35?, 160 MM WORKING LENGTH, AUTOCLAVABLE |
| Generic Name | MEDIASTINOSCOPE, SURGICAL |
| Product Code | EWY |
| Date Received | 2016-05-25 |
| Model Number | WA52050A |
| Catalog Number | WA52050A |
| ID Number | 04042761077590 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-25 |