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

Model Number ENDOSONIC CLEANER

Device Problem Insufficient Information (3190)

Patient Problem No Patient Involvement (2645)

Event Date 05/07/2014

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 the 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.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 subject device has been returned to the user.The device was returned to (b)(4) for servicing/repair after the event.(b)(4) observed that there was a liquid stain in the bottom (not confirmed as to whether this was in the tank or the cleaner), the driver board had failed and one of the transducers had become detached from the tank and its electrode was slightly crushed.The endosonic cleaner was not repaired and was returned to the healthcare facility who plan to purchase a new endosonic cleaner.(b)(4) took images of the transducers and these have been passed to keymed as part of the investigation.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 ENDOSCONIC ULTRASONIC CLEANER
• Type of Device: ENDOSONIC CLEANER
• Manufacturer (Section D): KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT), LTD.; southend-on-sea, essex ; UK
• Manufacturer Contact: alison prior, ra manager ; journeyman's way, temple farm; industrial estate; southend-on-sea, essex SS2 5-TF ; UK SS2 5TF ; 1702616333
• MDR Report Key: 4015896
• MDR Text Key: 4876003
• Report Number: 9611174-2014-00009
• 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: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• 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: 21123477
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1