MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-NP2 WORKSTATION SET 2 (US); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10021769

Device Problem Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2019

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.However, based on the initial investigation, it appears that the wall power outlet was defective or the plug from the wm-np2 cart.The user facility was recommended replacing power cord, and provided p/n to customer.Also recommended having an olympus fse dispatched to check for proper operation of cart wm-np2.If additional and significant information becomes available at a later time, this report will be supplemented.

Event Description

The user facility reported that prior to a case, there was smoke noted from the wm-np2 power cord at the power outlet.There was no patient or user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information from user facility regarding the procedure.Additional information received from the user facility states that the cart, connections and equipment were inspected prior to use.The cart was grounded prior to activation.The cart did not fall on the patient or staff.There was no injury.There was no patient was not in the room.The cart was last serviced 6 months prior to the incident.The cart will not be returned for evaluation.

• Brand Name: WM-NP2 WORKSTATION SET 2 (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: 8782886
• MDR Text Key: 150802294
• Report Number: 2951238-2019-01003
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

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: K10021769
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 07/30/2019
• Supplement Dates FDA Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1