MAUDE Adverse Event Report: KEYMED (MEDICAL AND INDUSTRIAL EQUIPMENT) LTD. WM-NP2 WORKSTATION SET 1 (JP); WM-*P2 SERIES OF ENDOSCOPY WORKSTATIONS

Model Number K10021766

Device Problems Melted (1385); Device Emits Odor (1425); Loss of Power (1475)

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

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

Photos provided by olympus (b)(6) show that one socket on the transformer of the workstation has melted.Olympus keymed have requested that the product is returned for further investigation.A follow up report will be submitted once the investigation has been completed.

Event Description

Power to a light source turned off during pre-inspection.A burning smell was detected, it was found that the socket on the insulating transformer had melted.The light source was plugged into another vacant socket on the transformer and the examination continued.No damage to the patient's health occured.

Manufacturer Narrative

Olympus keymed investigation completed.Conclusion of investigation: the failure occured due to an incorrect insertion or a "pulling" of the connector from the outlet, thus creating a high resistance path (or possibly a break in the circuit, which due to the inductive nature of the transformer can strike an arc).This is attributed to user misuse and/or inadequate maintenance (in not detecting early signs of this failure).

• Brand Name: WM-NP2 WORKSTATION SET 1 (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: 9780552
• MDR Text Key: 199825339
• Report Number: 9611174-2020-00012
• 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: Health Professional
• Device Model Number: K10021766
• 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