MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-02-25 for WM-NP2 WORKSTATION SET 1 (US) K10021764 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[137021842]
The device was not returned to olympus for evaluation. The cause of the reported broken wheel cannot be determined at this time. If additional information becomes available, this report will be updated and supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[137021843]
Olympus was informed that post an emergency case an employee sustained a shoulder sprain, while wheeling the cart down the user facility? S hallway. The injury occurred when the cart? S tray rolled out during transport on its own and had to be pushed back into place. The user facility reported that cart and its equipment did not fall on the employee. The course of treatment is unknown; however, the employee was sent to an occupational md, post care.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00459 |
| MDR Report Key | 8366793 |
| Report Source | USER FACILITY |
| Date Received | 2019-02-25 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-01-29 |
| Date Mfgr Received | 2019-01-29 |
| Date Added to Maude | 2019-02-25 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WM-NP2 WORKSTATION SET 1 (US) |
| Generic Name | WM-*P2 |
| Product Code | FEM |
| Date Received | 2019-02-25 |
| Model Number | K10021764 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. |
| Manufacturer Address | KEYMED HOUSE, STOCK ROAD SOUTHEND-ON-SEA, ESSEX SS2 5QH UK SS2 5QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-25 |