MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-T2 TRANSFORMER SPARE 100V; WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10021907

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437); Smoking (1585); Sparking (2595); Electrical Power Problem (2925)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

There has been no report of injury to patient or user.Olympus keymed have requested that the transformer for the wm-np2 workstation is returned for further investigation.Reported in an abundance of caution.

Event Description

The event occurred at the end of the procedure.There were no failures with the devices mounted on the wm-np2 workstation.No alarm occurred from the isolation power system in the operating room.It was reported 'although generation of smoke etc.Is not confirmed in fact, since it is burnt, it is estimated that a spark etc.Had occurred'.

Manufacturer Narrative

Olympus keymed investigation completed.Outcome of investigation was a loose connection in the transformer and a connector overheated.Safety mechanisms within the transformer operated as intended (fuses).The issue would have been easily detected by the user and should have submitted the device for service/repair prior to the failure.Recommendations for maintenance and repair was not followed by the user as described within the instructions for use.Service history for the equipment was unavailable.

• Brand Name: WM-T2 TRANSFORMER SPARE 100V
• 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: 8864857
• MDR Text Key: 153504066
• Report Number: 9611174-2019-00015
• 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: 10/18/2019

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: No Information
• Device Model Number: K10021907
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: 10/15/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1