MAUDE Adverse Event Report: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD. OLYMPUS ENDOSONIC ULTRASONIC CLEANER; ENDOSONIC CLEANER

Model Number ENDOSONIC CLEANER

Device Problems Thermal Decomposition of Device (1071); Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 01/09/2015

Event Type  malfunction  

Event Description

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 a smell of burning from inside of the cleaner was observed by healthcare facility staff.There is no patient involvement in this event.There was no report of user injury and this report is submitted in an abundance of caution.

Manufacturer Narrative

The event took place in (b)(6).The device was returned to the (b)(4) plant after the event where an initial investigation took place.The initial investigation was unable to confirm the burnt smell, but an abnormal noise occurred from inside the endosonic cleaner.One of the endosonic transducers had become detached from the cleaning tank.An image from the initial investigation has been passed to keymed.Keymed are awaiting the return of the subject device to enable a full investigation to be undertaken.There is no patient involvement in this event.There was no report of user injury and this report is submitted in an abundance of caution.

• Brand Name: OLYMPUS ENDOSONIC ULTRASONIC CLEANER
• Type of Device: ENDOSONIC CLEANER
• Manufacturer (Section D): KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.; southend-on-sea ; UK
• Manufacturer Contact: alison prior, manager ; journeyman's way, temple farm; industrial estate; southend-on-sea, essex SS2 5-TF ; UK SS2 5TF ; 1702616333
• MDR Report Key: 4512091
• MDR Text Key: 5491234
• Report Number: 9611174-2015-00001
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: ENDOSONIC CLEANER
• Device Catalogue Number: 7500617
• Device Lot Number: 21300589
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1