MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-01 for WM-NP1 A/S K10004537 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[110079956]
Olympus keymed have requested the return of the castor for further investigation. No report of injury to patient or user. Reported in abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[110079957]
Technician description: at the wm-np1 viano demo workstation (k23000264) a wheel broke off (wheel without brake). The wm-np1 was not overturned because the staff were able to hold up the workstation. No one was injured. The error analysis from (b)(6) has shown that the internal thread on the base plate of the workstation is worn. A repair of the wm-np1 workstation is not possible. The defective wm-np1 workstation needs to be replaced. A loaner workstation was provided to the customer on (b)(6) 2018. Until the arrival of the loaner, the customer continued to use the defective workstation (defective wheel was temporarily replaced). (b)(6) will send the broken wheel and pictures for further investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00008 |
| MDR Report Key | 7559660 |
| Date Received | 2018-06-01 |
| Date of Report | 2018-08-01 |
| Date Mfgr Received | 2018-07-30 |
| Date Added to Maude | 2018-06-01 |
| 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-NP1 A/S |
| Generic Name | WM-*P1 SERIES OF ENDOSCOPY WORKSTATIONS |
| Product Code | FEM |
| Date Received | 2018-06-01 |
| Model Number | K10004537 |
| 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 | 2018-06-01 |