MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-10 for ENDOSONIC CLEANER 100V (OT) 7500617 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[97480954]
Okm m-bc will be requesting the product to be returned for further investigation. No alleged report of injury to patient or user.
Patient Sequence No: 1, Text Type: N, H10
[97480955]
Endosonic arrived with nagano olumpus at the request for repair, because there was a description that seemed to have been shocked to the content of the request, it was confirmed to the dealer that there was no health damage but the nurse was turned on (ultrasound off) when she touched the tank with a state, she received a report that she received a feeling that the electricity flowed like flowing. This device confirmed the leakage at nagano ol, but there was no abnormality. Repair request content: the service got a repair request the other day and it was returned without any abnormality and it seemed that there was electric leak when checking at the facility. Put a switch for checking the unrepaired item, and when the nurse touched the cleaning tank, the service felt like the electricity flowed. Please check again. Last repair request (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611174-2018-00002 |
| MDR Report Key | 7177740 |
| Date Received | 2018-01-10 |
| Date of Report | 2018-04-16 |
| Date Mfgr Received | 2018-04-04 |
| Device Manufacturer Date | 2010-12-31 |
| Date Added to Maude | 2018-01-10 |
| 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 | ENDOSONIC CLEANER 100V (OT) |
| Generic Name | ENDOSONIC CLEANER |
| Product Code | FLG |
| Date Received | 2018-01-10 |
| Returned To Mfg | 2017-12-25 |
| 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 | 2018-01-10 |