MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for WM-W260 110-120V US K7505190 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[112721810]
Olympus keymed have requested the return of the product for further investigation. No report of injury to patient or user. Reported in an abundance of caution. A follow-up report will be provided with additional information once investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[112721811]
Event translated from (b)(6) using (b)(6) translate: during inspection, smoke was generated from the workstation (wm - 260). The inspection was completed by replacing the workstation. There were no reports of injury to patients or medical staff. The product has had a considerably long service life, and the event occurred due to the age of the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00010 |
| MDR Report Key | 7637034 |
| Date Received | 2018-06-26 |
| Date of Report | 2018-09-17 |
| Date of Event | 2018-06-19 |
| Date Mfgr Received | 2018-09-07 |
| Device Manufacturer Date | 2003-01-01 |
| Date Added to Maude | 2018-06-26 |
| 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 PETER MORCOS |
| Manufacturer Street | KEYMED HOUSE, STOCK ROAD |
| Manufacturer City | SOUTHEND ON SEA, ESSEX SS25QH |
| Manufacturer Country | UK |
| Manufacturer Postal | SS25QH |
| Manufacturer Phone | 0441702616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WM-W260 110-120V US |
| Generic Name | WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2018-06-26 |
| Model Number | K7505190 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |