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 2017-07-07 for WM-NP2 WORKSTATION SET 5 (US) K10021612 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[79738042]
The device was not returned to olympus for evaluation. The cause of the reported event cannot be determined at this time; however, the instruction manual warns users "check the security and condition of castors at six-monthly intervals. If loose and/or excessively worn, contact olympus for service. "
Patient Sequence No: 1, Text Type: N, H10
[79738043]
Olympus was informed that during transport for preparation of use the workstation front right castor wheel broke off causing the cart to be tilted. There was no user injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00442 |
| MDR Report Key | 6695565 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-07-07 |
| Date of Report | 2017-12-20 |
| Date of Event | 2017-06-16 |
| Date Mfgr Received | 2017-12-04 |
| Device Manufacturer Date | 2017-02-13 |
| Date Added to Maude | 2017-07-07 |
| 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 | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WM-NP2 WORKSTATION SET 5 (US) |
| Generic Name | WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2017-07-07 |
| Model Number | K10021612 |
| Catalog Number | K10021612 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-07 |