MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-11-13 for OLYMPUS WM-NP2 K10021610 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[91898402]
Initial investigation by olympus (b)(4) has confirmed that the castor on the rear-right side was disengaged. The bolt was assembled to the trolley body, and it was confirmed that the castor and the bolt were disconnected. Images provided by olympus (b)(4) show that the joint was broken. Keymed (medical and industrial equipment) ltd have requested the return of the subject device.
Patient Sequence No: 1, Text Type: N, H10
[91898403]
Wm-np2 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 (b)(6) where the workstation was moved between rooms during which the rear castor broke causing the workstation to fall against a nurse. Other staff members held the workstation to support its weight.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2017-00007 |
| MDR Report Key | 7025707 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-11-13 |
| Date of Report | 2017-12-05 |
| Date of Event | 2017-10-17 |
| Date Mfgr Received | 2017-12-05 |
| Device Manufacturer Date | 2017-01-23 |
| Date Added to Maude | 2017-11-13 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS AIMILIA GKARAFLI |
| Manufacturer Street | KEYMED HOUSE, STOCK ROAD |
| Manufacturer City | SOUTHEND ON SEA, ESSEX |
| Manufacturer Country | US |
| Manufacturer Phone | 0441702616 |
| Manufacturer G1 | KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD |
| Manufacturer Street | KEYMED HOUSE, STOCK ROAD |
| Manufacturer City | SOUTHEND ON SEA, ESSEX |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS |
| Generic Name | WM-NP2 ENDOSCOPY WORKSTATION |
| Product Code | FEM |
| Date Received | 2017-11-13 |
| Model Number | WM-NP2 |
| Catalog 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 | 2017-11-13 |