MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2016-06-08 for MEDIASTINOSCOPE, 35?, 160 MM WORKING LENGTH, AUTOCLAVABLE WA52050A manufactured by Olympus Winter & Ibe Gmbh.
[46855957]
The device was not returned to olympus for evaluation. Olympus followed up with the fda to obtain additional information regarding the reported event and the missing user facility information via telephone and in writing but with no result. The cause of the patient? S reported event cannot be determined. The instruction manual gives several warning to prevent patient injury:? If products are damaged or incomplete. Possible injury of patient, user or third person. Run through the checks before and after each use. Do not use products which are damaged or incomplete or have loose parts. Return damaged products together with loose parts for repair. Do not attempt to do any repairs yourself. Perform visual check: check the mediastinoscope, in particular in the distal area of the spatula or the tube, respectively, for damage, sharp edges and rough surfaces. Danger of injury when inserting or spreading the mediastinoscope! Inadvertent tissue damage is possible: when inserting the instrument in the mediastinum in spread or open condition, when spreading the mediastinoscope in the mediastinum. The anatomical situation must be observed. Insert the mediastinoscope only in closed condition. Spread only under observation through the scope.?
Patient Sequence No: 1, Text Type: N, H10
[46855958]
Olympus was informed via a voluntary medwatch (mw5061853) that following a mediastinoscopy for lung cancer staging using a video mediastinoscope, the patient developed vocal cord paralysis presumably, secondary to recurrent laryngeal nerve injury. The physician alleged that the complication occurred due to a faulty design with the surgical instrument which left patients susceptible for this complication. This is only one of several patients that experienced the same complication following the same procedure with the same instrument. The physician reported that there were at least four other patients all of whom developed vocal cord paralysis following this procedure. This report 1 of 5.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2016-00484 |
| MDR Report Key | 5707583 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2016-06-08 |
| Date of Report | 2016-06-08 |
| Date of Event | 2016-02-12 |
| Date Mfgr Received | 2016-05-19 |
| Date Added to Maude | 2016-06-08 |
| 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 | 3 |
| Brand Name | MEDIASTINOSCOPE, 35?, 160 MM WORKING LENGTH, AUTOCLAVABLE |
| Generic Name | MEDIASTINOSCOPE |
| Product Code | EWY |
| Date Received | 2016-06-08 |
| Model Number | WA52050A |
| Catalog Number | WA52050A |
| Lot Number | N/A |
| ID Number | 04042761077590 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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. Other | 2016-06-08 |