MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for ENDOSONIC CLEANER 100V (OT) 7500617 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[128296653]
No report of injury to patient or user. Initial findings following olympus (b)(4) investigation is that burnt smell was caused by dust. The endosonic was not regularly maintained as advised by the instructions for use. Olympus keymed have requested the product is returned for further investigation. Reported in an abundance of caution.
Patient Sequence No: 1, Text Type: N, H10
[128296654]
A burnt smell occurred from endosonic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00019 |
| MDR Report Key | 8055711 |
| Date Received | 2018-11-09 |
| Date of Report | 2019-01-03 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2019-01-02 |
| Device Manufacturer Date | 2009-11-02 |
| Date Added to Maude | 2018-11-09 |
| 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 | ENDOSONIC CLEANER 100V (OT) |
| Generic Name | ENDOSONIC CLEANER |
| Product Code | FLG |
| Date Received | 2018-11-09 |
| Returned To Mfg | 2018-10-30 |
| Model Number | 7500617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2018-11-09 |