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

Model Number K10021611

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/18/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The user was advised that the power cable needs to be replaced as the cut that is repaired by wrapping the cut area with electrical tape can lead to smoking or a fire.It was also advised to have biomedical engineer run a test on the power supply of the cart to make sure there is no damage or malfunctions.

Event Description

It was reported approximately 10-15 minutes into an unspecified procedure, the users smelled smoke and saw that the smoke was coming out of the power cable that was plugged into the wall socket.A cut on the power cable was observed.According to the reporter, the cut observed was wrapped with electrical tape.There was no reported patient/user harm or injury due to the incident.

Manufacturer Narrative

This supplemental report #1 updates the following section: b5,g4,g7,h2,h6 and h10.According to the reporter, it is believed that the power outlets from the wall were at fault.The nurse stated that the outlets in the room were loose.The device will not be returned as no repairs were needed.Site clinical engineering checked each device on the cart and only the power cable was found damaged.If additional information becomes available this report will be supplemented accordingly.

Event Description

The intended procedure was a diagnostic laparoscopy.The procedure was able to be completed with another wm-np2.The device was plugged into a different wall plug.The device was inspected prior to use.It is unknown what other devices were used in conjunction with the work station.It was not confirmed that the cut on the cord wrapped with electrical tape caused the smoking.According to clinical engineering the cord was inspected prior to use and the power cord was hospital grade.The physician was not experienced in using the device.

• Brand Name: WM-NP2 WORKSTATION SET 4 (US)
• 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: 10056017
• MDR Text Key: 190938188
• Report Number: 9611174-2020-00019
• Device Sequence Number: 1
• Product Code: FEM
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: K10021611
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2020
• Initial Date FDA Received: 05/14/2020
• Supplement Dates Manufacturer Received: 05/15/2020
• Supplement Dates FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1