MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-13 for OLYMPUS VIDEO MEDIASTINOSCOPE WA52050A manufactured by Olympus.
[42970457]
The patient underwent a surgical procedure for lung cancer, including mediastinoscopy, lobectomy by a vats approach which was complicated by bilateral vocal cord paralysis. This necessitated urgent tracheostomy to protect the patients airway and eventual gastrostomy to provide a means for alimentation. It is unknown why both vocal cords were affected with one likely due to the tumor extension into the mediastinum. However the contralateral vocal cord was also injured, likely during mediastinoscopy. It is my suspicion that the video-mediastinoscope design contributed to this injury. The scope is manufactured by (b)(4) and is model #wa52050a and is decidedly different in design and function to the point that 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 | MW5061743 |
| MDR Report Key | 5584292 |
| Date Received | 2016-04-13 |
| Date of Report | 2016-04-13 |
| Date of Event | 2015-04-30 |
| Date Added to Maude | 2016-04-18 |
| 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 |
| 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 | OLYMPUS VIDEO MEDIASTINOSCOPE |
| Generic Name | OLYMPUS VIDEO MEDIASTINOSCOPE |
| Product Code | EWY |
| Date Received | 2016-04-13 |
| Model Number | WA52050A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-04-13 |