MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-NP2 WORKSTATION SET 4 (JP); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10021610

Device Problems Fire (1245); Melted (1385); Smoking (1585)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 02/26/2020

Event Type  malfunction  

Manufacturer Narrative

Olympus keymed have requested that the power cable is returned for further investigation.A follow up report will be submitted once an investigation has been completed.

Event Description

The wm-np2 workstation was plugged into the facilities mains during preparation for use.Fire and smoke came from the plug on the power cable.One pin of the outlet terminal (plug) is missing - it appears to have melted.The operation was conducted using another workstation.There was no patient health damage.

Manufacturer Narrative

Olympus keymed investigaiton has been completed.Outcome of investigation is as follows: the mains cable was found to be twisted and deformed.It was determined that the workstation had been moved with the mains cable attached to the wall outlet socket repeatedly.The logical extension is that the unit was either powered up with the plug partially pulled from the wall socket, or that the unit was or moved (with the unit powered on) and the plug became pulled partially from the wall socket.The conclusion is user error in handling of the workstation, and lack of maintenance actions (specifically the status of the mains inlet cable) both specified in the instructions for use.

• Brand Name: WM-NP2 WORKSTATION SET 4 (JP)
• Type of Device: WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS
• 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: 9780641
• MDR Text Key: 184889590
• Report Number: 9611174-2020-00013
• Device Sequence Number: 1
• Product Code: FEM
• 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: 04/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: K10021610
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1