MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-19 for WM-WP1 220-240V EU K10001335 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[103037463]
Castor has been returned to keymed ( medical & industrial equipment) ltd - the manufacturer. Investigation is currently in progress. No report of injury to patient or user.
Patient Sequence No: 1, Text Type: N, H10
[103037464]
The olympus wm-np1 mobile workstation is intended for use in medical facilities under the direction of a trained physician, and has been designed to be used with a range of olympus equipment to facilitate gi endoscopy, endoscopic ultrasound, respiratory and surgical endoscopic procedures. Keymed ( medical and industrial equipment) ltd has been made aware of an event in germany, where the left rear castor of the workstation had broken. The subject device (castor) been replaced on (b)(6) 2018 - repair facility not specified. The workstation was being manoeuvred between locations in the clinic and the event took place when the workstation was manuovered over a threshold, causing the workstation to tilt forward. No report of damage to concomittal devices on the workstation. There are no reports of injury to the user or other persons. This report is submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00006 |
| MDR Report Key | 7348063 |
| Date Received | 2018-03-19 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-04-23 |
| Device Manufacturer Date | 2007-02-06 |
| Date Added to Maude | 2018-03-19 |
| 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 | MR PETER MORCOS |
| Manufacturer Street | KEYMED HOUSE, STOCK ROAD |
| Manufacturer City | SOUTHEND ON SEA, ESSEX |
| Manufacturer Country | US |
| Manufacturer Phone | 0441702616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WM-WP1 220-240V EU |
| Generic Name | WM-WP1 220-240V EU |
| Product Code | FEM |
| Date Received | 2018-03-19 |
| Returned To Mfg | 2018-03-08 |
| Model Number | K10001335 |
| Lot Number | 2704478 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-03-19 |