MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-14 for ENDOSONIC CLEANER 110-120V (OAI) 7500618 manufactured by Keymed (medical And Industrial Equipment) Ltd..
[80137841]
The device was not returned to olympus for evaluation. The cause of the reported event could not be determined. As part of our investigation, olympus made multiple follow ups with the user facility by telephone and in writing in an attempt to gather additional information on the reported event; however, no additional information was obtained. If additional information becomes available or if the device is returned at a later time, this report will be supplemented.
Patient Sequence No: 1, Text Type: N, H10
[80137842]
Olympus was informed that during the maintenance of the device at the user facility, the technician was shocked. There was no patient involvement with the device. The tech's condition is unknown at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2017-00459 |
| MDR Report Key | 6716199 |
| Date Received | 2017-07-14 |
| Date of Report | 2017-07-14 |
| Date Mfgr Received | 2017-06-22 |
| Date Added to Maude | 2017-07-14 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDOSONIC CLEANER 110-120V (OAI) |
| Generic Name | ENDOSONIC CLEANER |
| Product Code | FLG |
| Date Received | 2017-07-14 |
| Model Number | 7500618 |
| Catalog Number | 7500618 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 SS2 5QH UK SS2 5QH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-07-14 |