MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. ENDOSONIC CLEANER 100V (OT)

Model Number 7500617

Device Problems Circuit Failure (1089); Solder Joint Fracture (2324); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

No report of injury to patient or user.Initial findings following olympus (b)(4) investigation is that burnt smell was caused by dust.The endosonic was not regularly maintained as advised by the instructions for use.Olympus keymed have requested the product is returned for further investigation.Reported in an abundance of caution.

Event Description

A burnt smell occurred from endosonic.

Manufacturer Narrative

Olympus keymed investigation completed.Failure was a known fault defective solder joints on transducer tabs.A design change was implemented and a service bulletin created to cover this mode of failure.There has been no report of injury to patient or user.This event was reported in an abundance of caution.This will be the final follow up report.However, if any new information is received the case will be re-opened and investigated further.

• Brand Name: ENDOSONIC CLEANER 100V (OT)
• Type of Device: ENDOSONIC CLEANER
• Manufacturer (Section D): KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD.; keymed house, stock road; southend-on-sea, essex
• MDR Report Key: 8055711
• MDR Text Key: 128296653
• Report Number: 9611174-2018-00019
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• PMA/PMN Number: CLASS 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7500617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1