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

Model Number 7500617

Device Problems Leak/Splash (1354); Misassembled (1398); Unintended Electrical Shock (4018)

Patient Problems Electric Shock (2554); No Information (3190)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Olympus (b)(4) have requested the product is returned for further investigation.A follow up report will be submitted once the investigation has been completed.

Event Description

A feeling of electrification (electric leakage) was confirmed when touching the main unit and surrounding water supply during endosonic operation at a facility.Verification has not been carried out at the facility.However, it is judged that the main body has a leak because it occurred only during endosonic operation.

Manufacturer Narrative

Olympus keymed investigation completed.It was identified that the unit was not used according to information provided within the instructions for use (ifu) which states the unit shall be functionally earthed.The customer had used a 2 pin adaptor and therefore not adequately earthed the unit.It has therefore been determined that the customer had used a 3rd party device between the unit and the mains connection which has compromised the earth connection of the unit, therefore this has been considered as user misuse.The customer was immediately contacted and informed them to discontinue the use of the 3rd party adaptor.

• 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 SS2 5 QH; UK SS2 5QH
• MDR Report Key: 8763618
• MDR Text Key: 150145775
• Report Number: 9611174-2019-00012
• 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
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• 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?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other