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

Model Number ENDOSONIC CLEANER

Device Problems Device Emits Odor (1425); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2014

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 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 an error "e3" message appeared on the display of the subject device.The user turned the device off and on and used it several times, after that it smelled like something was burning.There was no report of user injury and this report is submitted in an abundance of caution.

Manufacturer Narrative

The subject device has been repaired and returned to the user.Keymed has requested a copy of the repair report.A review of the ifu shows the description of the e3 error message to be 'the electrical power supply has momentarily dipped below the level necessary for the cleaner to function correctly.Set the switch to o for ten seconds and then back to/to reset the cleaner to normal operations.'.

• 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, ra mgr ; journeyman's way; temple farm industrial estate; southend-on-sea, essex SS2 5-TF ; UK SS2 5TF ; 0170261633
• MDR Report Key: 3979976
• MDR Text Key: 4637321
• Report Number: 9611174-2014-00005
• 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: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2014
• 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: 2709537
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2007
• 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