MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-04 for ENDOSONIC CLEANER 220-240V 7500620 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[113631499]
Olympus keymed have requested the product to be returned for further investigation. Based on the information provided this complaint has been reported in the abundance of caution, further information has been requested regarding this event and a follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[113631500]
The customer reported that they got "micro shocks".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00011 |
| MDR Report Key | 7661899 |
| Date Received | 2018-07-04 |
| Date of Report | 2018-08-09 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2009-02-20 |
| Date Added to Maude | 2018-07-04 |
| 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 220-240V |
| Generic Name | ENDOSONIC CLEANER |
| Product Code | FLG |
| Date Received | 2018-07-04 |
| Model Number | 7500620 |
| 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 | 2018-07-04 |