MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-21 for OLYMPUS VIDEO MEDIASTINOSCOPE WA52050A manufactured by Olympus.
[43632824]
Following mediastinoscopy for lung cancer staging using a video mediastinoscope, the patient developed vocal cord paralysis presumably, secondary to recurrent laryngeal nerve injury. It is my professional opinion this complication occurred due to a faulty design of the surgical instrument which by its design placed the patient in harms way for this complication. This is only one of several patients that experienced the same complication following the same procedure with the same instrument. I know of at least four other patients all of whom developed vocal cord paralysis following this procedure, which typically carries a complication rate of 1-2% for this complication. In my practice using a different instrument, this complication had not occurred at all. It is my belief the instrument design and function is the basic problem which led to the complication observed in each of these patients.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061853 |
| MDR Report Key | 5603436 |
| Date Received | 2016-04-21 |
| Date of Report | 2016-04-21 |
| Date of Event | 2016-02-12 |
| Date Added to Maude | 2016-04-25 |
| 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 | 2016-04-21 |
| Model Number | WA52050A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-04-21 |