MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-02-19 for WM-NP2 WORKSTATION SET 2 (US) K10021769 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[136502840]
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
[136502841]
Olympus was informed that a nurse was injured when the castor wheel broke off the workstation while being maneuvered. The user facility? S department manager reported that the workstation had been taken out of service due to the broken wheel and that the nurse was made aware of this. The nurse reportedly forgot and pushed the workstation which caused the other equipment to fall. The nurse was placed on home rest for two days and then returned to regular work duties.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00439 |
| MDR Report Key | 8350474 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-02-19 |
| Date of Report | 2019-02-19 |
| Date Mfgr Received | 2019-01-25 |
| Date Added to Maude | 2019-02-19 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 2 (US) |
| Generic Name | WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2019-02-19 |
| Model Number | K10021769 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-02-19 |