MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2015-04-10 for OLYMPUS ENDOSONIC ULTRASONIC CLEANER ENDOSONIC CLEANER 7500617 manufactured by Keymed (medical & Industrial Equipment), Ltd..
[5710874]
The olympus endosonic ultrasonic cleaner is a product which enables the cleaning of olympus endoscopic accessories and ancillary equipment by qualified technical or nursing staff in the cleaning room of a medical facility where flexible endoscopic accessories are reprocessed. The items to be cleaned are placed in a purpose designed basket and then immersed in the endosonic tank, which is filled to the appropriate level with ultrasonic cleaning solution. The fluid is agitated ultrasonically to remove debris and contamination from the items. Following cleaning, the items must be reprocessed in line with their instructions for use. Keymed has been made aware of an event where during the cleaning process, the facility staff smelled something burning from the inside of the endosonic cleaner. There is no report of injury to patient nor user and this report is submitted in an abundance of caution.
Patient Sequence No: 1, Text Type: D, B5
[13203118]
An initial investigation has taken place at olympus (b)(4), which has confirmed that a transducer has become detached from the underside of the tank and that the adhesive which bonds the transducer to the tank has a burned appearance. Keymed are awaiting the return of the subject device. Once this happens a full investigation will take place.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611174-2015-00003 |
| MDR Report Key | 4693136 |
| Report Source | 01,06,07 |
| Date Received | 2015-04-10 |
| Date of Report | 2015-03-16 |
| Date of Event | 2015-02-26 |
| Date Mfgr Received | 2015-03-16 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2015-05-26 |
| 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 | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ALISON PRIOR, RA MANAGER |
| Manufacturer Street | JOURNEYMAN'S WAY, TEMPLE FARM INDUSTRIAL ESTATE |
| Manufacturer City | SOUTHEMD ON SEA, ESSEX SS2 5TF |
| Manufacturer Country | UK |
| Manufacturer Postal | SS2 5TF |
| Manufacturer Phone | 1702616333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OLYMPUS ENDOSONIC ULTRASONIC CLEANER |
| Generic Name | ENDOSONIC CLEANER |
| Product Code | FLG |
| Date Received | 2015-04-10 |
| Model Number | ENDOSONIC CLEANER |
| Catalog Number | 7500617 |
| Lot Number | 21213284 |
| Operator | OTHER |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. |
| Manufacturer Address | SOUTHEND-ON-SEA UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-10 |