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

Model Number 7500617

Device Problems Electrical /Electronic Property Problem (1198); Leak/Splash (1354); Inappropriate/Inadequate Shock/Stimulation (1574); Facilities Issue (2935)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Okm m-bc will be requesting the product to be returned for further investigation.No alleged report of injury to patient or user.

Event Description

Endosonic arrived with nagano olumpus at the request for repair, because there was a description that seemed to have been shocked to the content of the request, it was confirmed to the dealer that there was no health damage but the nurse was turned on (ultrasound off) when she touched the tank with a state, she received a report that she received a feeling that the electricity flowed like flowing.This device confirmed the leakage at nagano ol, but there was no abnormality.Repair request content: the service got a repair request the other day and it was returned without any abnormality and it seemed that there was electric leak when checking at the facility.Put a switch for checking the unrepaired item, and when the nurse touched the cleaning tank, the service felt like the electricity flowed.Please check again.Last repair request (b)(4).

Manufacturer Narrative

Subject device returned to manufacturer, visual and microscopic inspection of the cable has taken place.Investigator concluded that the equipment has been operated without a viable earth connection (in contravention of ifu stated power supply requirements ¿ section 4.3) thus preventing any leakage current being safely carried away to earth.An 'adaptor' has been attached to the standard 3 pin plug supplied with the subject device.The 'adaptor' is not manufactured or supplied by olympus.Fault not caused by subject device but by the third party 'adaptor'.This will be submitted as the final follow-up report and the complaint will be closed.However, if any new information is provided the complaint will be re-opened.

• 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: 7177740
• MDR Text Key: 97480954
• Report Number: 9611174-2018-00002
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• PMA/PMN Number: PCLASS 1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7500617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2017
• Date Manufacturer Received: 04/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1