MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-25 for WM-NP2 WORKSTATION SET 4 (JP) K10021610 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[98428170]
We are awaiting further information from olympus (b)(4). We have requested the serial number and further clarification and images. There was no reported injury to patient or user. We will be requesting the return of the product for further investigation.
Patient Sequence No: 1, Text Type: N, H10
[98428191]
Castor broke when moved. Market quality assurance dept. (b)(6) ((b)(6) 2018 ). I judged this phenomenon corresponded to pae due to the risk of falling the subject wm-np2. I changed pae question 2 from no to yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00003 |
| MDR Report Key | 7219106 |
| Date Received | 2018-01-25 |
| Date of Report | 2018-03-16 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2011-11-16 |
| Date Added to Maude | 2018-01-25 |
| 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 | 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-NP2 WORKSTATION SET 4 (JP) |
| Generic Name | WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2018-01-25 |
| Model Number | K10021610 |
| Device Availability | Y |
| 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 | 2018-01-25 |