MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-19 for MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM) MON-000005 manufactured by Auris Health, Inc..
[187016563]
The device was not returned for evaluation. There was no allegation of device failure. The risk of pneumothorax is documented in 105-000198-01, rev e, monarch bronch risk management report. Based on the information available for this complaint, the root cause of the reported event is related to a known inherent risk of the device and procedure as documented in the device labeling.
Patient Sequence No: 1, Text Type: N, H10
[187016564]
A few days after a successful biopsy procedure, a pneumothorax in the right lower lobe was discovered and reported by the physician on (b)(6) 2020. A chest tube was placed to resolve the pneumothorax. The patient recovered and was released on (b)(6) 2020.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3014447948-2020-00004 |
| MDR Report Key | 9855554 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2019-09-03 |
| Date Added to Maude | 2020-03-19 |
| 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 | MRS. ADITI GHIRNIKAR |
| Manufacturer Street | 150 SHORELINE DRIVE |
| Manufacturer City | REDWOOD CITY CA |
| Manufacturer G1 | AURIS HEALTH, INC. |
| Manufacturer Street | 150 SHORELINE DRIVE |
| Manufacturer City | REDWOOD CITY CA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MONARCH ENDOSCOPY PLATFORM (MONARCH PLATFORM) |
| Generic Name | BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES |
| Product Code | EOQ |
| Date Received | 2020-03-19 |
| Model Number | MON-000005 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AURIS HEALTH, INC. |
| Manufacturer Address | 150 SHORELINE DRIVE REDWOOD CITY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-19 |